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What changed in TG THERAPEUTICS, INC.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of TG THERAPEUTICS, INC.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+758 added−672 removedSource: 10-K (2025-03-03) vs 10-K (2024-02-29)

Top changes in TG THERAPEUTICS, INC.'s 2024 10-K

758 paragraphs added · 672 removed · 505 edited across 4 sections

Item 1. Business

Business — how the company describes what it does

76 edited+16 added−22 removed162 unchanged
Biggest changeAlthough litigation and legislation over the Affordable Care Act are likely to continue, with unpredictable and uncertain results, we expect that the Biden administration may seek to expand and strengthen the Affordable Care Act. ​ 17 Table of Contents On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (the Act), which, among other provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms.
Biggest changeLitigation and legislation over the Affordable Care Act are likely to continue, with unpredictable and uncertain results, and the new U.S. administration and recent congressional seat turnover may result in increased regulatory and economic uncertainty with respect to the Affordable Care Act. ​ 20 Table of Contents The Inflation Reduction Act of 2022 (the IRA) includes, among other provisions, several measures intended to lower the cost of prescription drugs and related healthcare reforms, such as requiring manufacturers of certain drugs to engage in price negotiations with Medicare beginning in 2026, imposing rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replacing the Part D coverage gap discount program with a new discounting program beginning in 2025.
Under the terms of the commercialization agreement, we received an upfront payment of $140 million, and are eligible to receive an additional $12.5 million upon launch in the first EU country and up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones.
Under the terms of the commercialization agreement, we received an upfront payment of $140 million and $12.5 million upon launch in the first EU country. We are eligible to receive up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones.
The expected expiration for the composition of matter patent is 2029 in the U.S. and 2025 in Europe and other non-U.S. jurisdictions, exclusive of patent term extensions, which could result in later expiration dates.
The expected expiration for the composition of matter patent in the U.S. is 2029 and in Europe and other non-U.S. jurisdictions, exclusive of patent term extensions which could result in later expiration dates, is 2025.
In exchange, Neuraxpharm will have the exclusive right to commercialize BRIUMVI in certain territories outside the United States, Canada and Mexico, the commercialization rights for which had been previously retained by TG, thus excluding certain Asian countries subject to previously existing partnerships.
In exchange, Neuraxpharm will have the exclusive right to commercialize BRIUMVI in certain territories outside the United States, Canada and Mexico, the commercialization rights for which had been previously retained by TG, thus excluding certain Asian countries subject to previously existing partnerships.
Upon achievement of certain near-term clinical or time-based milestones, the Company will make a further $7.5 million payment to Precision, a portion of which will also be an equity investment in Precision’s common stock at a pre-specified premium.
Upon the achievement of certain near-term clinical or time-based milestones, the Company will make a further $7.5 million payment to Precision, a portion of which will also be an equity investment in Precision’s common stock at a pre-specified premium.
If we were to experience any such delay that would negatively impact our business and timeline to commercialization of any of our drug candidates affected by such manufacturing issue. ​ 15 Table of Contents Post-Approval Requirements ​ Any products for which we receive FDA approval are subject to continuing regulation by the FDA and other federal and state regulators on a wide range of matters, including, among other things cGMPs and product quality, pharmacovigilance and reporting of adverse events, product distribution requirements, fulfilling post-marketing or confirmatory study or REMS commitments, and complying with FDA promotion and advertising requirements.
If we were to experience any such delay that would negatively impact our business and timeline to commercialization of any of our drug candidates affected by such manufacturing issue. ​ 18 Table of Contents Post-Approval Requirements ​ Any products for which we receive FDA approval are subject to continuing regulation by the FDA and other federal and state regulators on a wide range of matters, including, among other things cGMPs and product quality, pharmacovigilance and reporting of adverse events, product distribution requirements, fulfilling post-marketing or confirmatory study or REMS commitments, and complying with FDA promotion and advertising requirements.
The FTC's guidance for appropriately securing consumers' personal information is similar to what is required under HIPAA. ​ 19 Table of Contents In addition, we may be subject to state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways, thus complicating compliance efforts.
The FTC's guidance for appropriately securing consumers' personal information is similar to what is required under HIPAA. ​ 22 Table of Contents In addition, we may be subject to state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways, thus complicating compliance efforts.
Decreases in third-party reimbursement for our drug candidates, if approved, or a decision by a third-party payor to not cover our drug candidates could reduce physician usage of such drugs and have a material adverse effect on our sales, results of operations and financial condition. ​ In the U.S., the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the Affordable Care Act, enacted in March 2010, has had a significant impact on the health care industry.
Decreases in third-party reimbursement for our drug candidates, if approved, or a decision by a third-party payor to not cover our drug candidates could reduce physician usage of such drugs and have a material adverse effect on our sales, results of operations and financial condition. ​ In the U.S., the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, collectively the Affordable Care Act, has had a significant impact on the health care industry.
The majority of states also have anti-kickback laws, which establish similar prohibitions and in some cases may apply to items or services reimbursed by any third-party payor, including commercial insurers. ​ 18 Table of Contents In addition, the civil False Claims Act prohibits, among other things, knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S. government.
The majority of states also have anti-kickback laws, which establish similar prohibitions and in some cases may apply to items or services reimbursed by any third-party payor, including commercial insurers. ​ 21 Table of Contents In addition, the civil False Claims Act prohibits, among other things, knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S. government.
It is impossible to predict whether further legislative or FDA regulation or policy changes will be enacted or implemented and what the impact of such changes, if any, may be. ​ 16 Table of Contents Should we wish to market our products outside the U.S., we must receive marketing authorization from the appropriate foreign regulatory authorities.
It is impossible to predict whether further legislative or FDA regulation or policy changes will be enacted or implemented and what the impact of such changes, if any, may be. ​ 19 Table of Contents Should we wish to market our products outside the U.S., we must receive marketing authorization from the appropriate foreign regulatory authorities.
We retain an option to buy back all rights under the commercialization agreement for a period of two years in the event of a change in control of TG. ​ TG-1701 (BTK inhibitor) ​ In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui, to acquire worldwide intellectual property rights, excluding Asia but including Japan, and for the research, development, manufacturing, and commercialization of products containing or comprising of any of Hengrui’s Bruton’s Tyrosine Kinase inhibitors containing the compounds of either TG 1701 (SHR1459 or EBI1459) or TG1702 (SHR1266 or EBI1266).
We retain an option to buy back all rights under the Commercialization Agreement for a period of two years in the event of a change in control of TG. ​ 13 Table of Contents TG-1701 (BTK inhibitor) ​ In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui, to acquire worldwide intellectual property rights, excluding Asia but including Japan, and for the research, development, manufacturing, and commercialization of products containing or comprising of any of Hengrui’s Bruton’s Tyrosine Kinase inhibitors containing the compounds of either TG 1701 (SHR1459 or EBI1459) or TG1702 (SHR1266 or EBI1266).
We also file patent applications directed to novel combinations of our drugs together and with drugs developed by others. The intellectual property portfolios for our most advanced drug candidates as of February 2024 are summarized below. Each of these portfolios contains one or more pending patent applications covering our products and product candidates and uses and combinations thereof.
We also file patent applications directed to novel combinations of our drugs together and with drugs developed by others. The intellectual property portfolios for our most advanced drug candidates as of February 2025 are summarized below. Each of these portfolios contains one or more pending patent applications covering our products and product candidates and uses and combinations thereof.
To receive Fast Track designation, an applicant must demonstrate: ● that the drug is intended to treat a serious or life-threatening condition; and ● that nonclinical or clinical data demonstrate the potential to address an unmet medical need. ​ 14 Table of Contents The FDA must respond to a request for Fast Track designation within 60 calendar days of receipt of the request.
To receive Fast Track designation, an applicant must demonstrate: ● that the drug is intended to treat a serious or life-threatening condition; and ● that nonclinical or clinical data demonstrate the potential to address an unmet medical need. ​ 17 Table of Contents The FDA must respond to a request for Fast Track designation within 60 calendar days of receipt of the request.
To attract qualified candidates, the Company offers an attractive total rewards package, consisting of base salary, cash bonus, a comprehensive benefit package, equity compensation, and 401(k) plan. Bonus opportunities and equity compensation increase as a percentage of total compensation based on level of responsibility, and actual bonus awards are based on performance. ​ 20 Table of Contents
To attract qualified candidates, the Company offers an attractive total rewards package, consisting of base salary, cash bonus, a comprehensive benefit package, equity compensation, and 401(k) plan. Bonus opportunities and equity compensation increase as a percentage of total compensation based on level of responsibility, and actual bonus awards are based on performance. ​ 23 Table of Contents
The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. ​ 13 Table of Contents Product Development and Applications for Marketing Authorization ​ The regulatory review and approval process is lengthy, expensive, and uncertain.
The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. ​ 16 Table of Contents Product Development and Applications for Marketing Authorization ​ The regulatory review and approval process is lengthy, expensive, and uncertain.
These patents and patent applications include composition of matter patents relating to azer-cel, as well as method of use patents which cover use of azer-cel. ​ Limitations on Patent Rights and Trade Secrets ​ The patent rights that we own or have licensed relating to our product candidates are limited in ways that may affect our ability to exclude third parties from competing against us if we obtain regulatory approval to market these product candidates.
These patents and patent applications include composition of matter patents relating to azer-cel, as well as method of use patents which cover use of azer-cel. ​ 12 Table of Contents Limitations on Patent Rights and Trade Secrets ​ The patent rights that we own or have licensed relating to our product candidates are limited in ways that may affect our ability to exclude third parties from competing against us if we obtain regulatory approval to market these product candidates.
The license will terminate on a country-by-country basis upon the expiration of the last licensed patent right or 15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated (i) by LFB if the Company challenges any of the licensed patent rights, (ii) by either party due to a breach of the agreement, or (iii) by either party in the event of the insolvency of the other party. ​ Ildong Pharmaceutical Co.
The license will terminate on a country-by-country basis upon the expiration of the last licensed patent right or 15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated (i) by LFB if the Company challenges any of the licensed patent rights, (ii) by either party due to a breach of the agreement, or (iii) by either party in the event of the insolvency of the other party.
This may be the case with respect to our pending patent applications referred to below. ​ BRIUMVI (ublituximab-xiiy) ​ Pursuant to our license for ublituximab with LFB Biotechnologies, GTC Biotherapeutics, and LFB/GTC LLC, we have the exclusive commercial rights to a series of patents and patent applications in the U.S. and in multiple countries around the world, as well as a non-exclusive license to additional background patent rights.
This may be the case with respect to our pending patent applications referred to below. ​ 11 Table of Contents BRIUMVI (ublituximab-xiiy) Pursuant to our license for ublituximab with LFB Biotechnologies, GTC Biotherapeutics, and LFB/GTC LLC, we have the exclusive commercial rights to a series of patents and patent applications in the U.S. and in multiple countries around the world, as well as a non-exclusive license to additional background patent rights.
We have a number of issued patents and pending patent applications related to our compounds and other technology, but we cannot guarantee the scope of protection of the issued patents, or that such patents will survive a validity or enforceability challenge, or that any of the pending patent applications will issue as patents. ​ Generally, patent applications in the U.S. are maintained in secrecy for a period of 18 months or more.
We have a number of issued patents and pending patent applications related to our compounds and other technology, but we cannot guarantee the scope of protection of the issued patents, or that such patents will survive a validity or enforceability challenge, or that any of the pending patent applications will issue as patents. 9 Table of Contents Generally, patent applications in the U.S. are maintained in secrecy for a period of 18 months or more.
STRATEGY As a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B cell mediated diseases, our key corporate objectives include: ● Successfully commercializing BRIUMVI in the U.S. for relapsing forms of multiple sclerosis; ● Building upon the BRIUMVI approval to evaluate other uses for BRIUMVI in additional MS indications and/or other autoimmune diseases; ● Continuing to expand our pipeline with mechanisms of importance to B-cell mediated diseases; ● Evaluating potential strategic collaborations to maximize the value of our programs and B-cell directed platform; and ● Maintaining our “patient first” culture as we grow our business. ​ Our Approach and Platform ​ Our approach to drug development is centered on developing therapies for B- cell mediated diseases.
STRATEGY As a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B cell mediated diseases, our key corporate objectives include: ● Successfully commercializing BRIUMVI in the U.S. for RMS; ● Building upon the BRIUMVI approval to evaluate other uses for BRIUMVI in additional MS indications and/or other autoimmune diseases; ● Continuing to expand our pipeline with mechanisms of importance to B-cell mediated diseases; ● Evaluating potential strategic collaborations to maximize the value of our programs and B-cell directed platform; and ● Maintaining our “patient first” culture as we grow our business. ​ Our Approach and Platform ​ Our approach to drug development is centered on developing therapies for B-cell mediated diseases.
In addition, while we believe not directly competitive, there is also a subcutaneous anti-CD20 monoclonal antibody approved for MS, ofatumumab (Novartis AG). ​ TG-1701, TG-1801 and azer-cel, if approved will also face competition from drugs on the market and under development in the same therapeutic class as each of those drugs. ​ Additional information can be found under Item “1A - Risk Factors – Other Risks Related to Our Business” within this report. 12 Table of Contents ​ SUPPLY AND MANUFACTURING ​ We have limited experience in manufacturing products for clinical or commercial purposes.
In addition, while we believe not directly competitive, there is also a subcutaneous anti-CD20 monoclonal antibody approved for MS, ofatumumab (Novartis AG). ​ Azer-cel, if approved will also face competition from drugs on the market and under development in the same therapeutic class as each of those drugs. ​ Additional information can be found under Item “1A - Risk Factors – Other Risks Related to Our Business” within this report. 15 Table of Contents ​ SUPPLY AND MANUFACTURING ​ We have limited experience in manufacturing products for clinical or commercial purposes.
Patents directed to the compound have granted in the U.S., Europe, and other jurisdictions, including Australia, Canada, Japan, China, and Korea and are expected to expire no sooner than October 2034.
Patents directed to the compound have granted in the U.S., Europe, and other jurisdictions, including Australia, Canada, Japan, China, and Korea and are expected to expire no sooner than October 2034. Applications are pending in other jurisdictions.
It is estimated that nearly 1 million people are living with MS in the United States and over 2.3 million people world-wide are living with MS. ​ ​ 6 Table of Contents OUR PRODUCTS We currently license worldwide development and commercial rights, subject to certain limited geographical restrictions, for all of our products under development.
It is estimated that nearly 1 million people are living with MS in the United States and over 2.3 million people world-wide are living with MS. ​​ OUR PRODUCTS We currently license worldwide development and commercial rights, subject to certain limited geographical restrictions, for all of our products under development.
Ltd.(Ildong) ​ In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong relating to the development and commercialization of ublituximab in South Korea and Southeast Asia.
Ildong Pharmaceutical Co. Ltd.(Ildong) In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong relating to the development and commercialization of ublituximab in South Korea and Southeast Asia.
Similar provisions are available in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug and have been filed for in certain European Patent (EP) countries. Also, under the Hatch-Waxman Act, drugs that are new chemical entities (NCEs) are eligible for a five-year period of marketing exclusivity in the United States.
Similar provisions are available in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug and have been filed for and granted in certain European Patent (EP) countries. 10 Table of Contents Also, under the Hatch-Waxman Act, drugs that are new chemical entities (NCEs) are eligible for a five-year period of marketing exclusivity in the United States.
With this approval, the centralized marketing authorization is valid in all EU member states, Iceland, Norway and Liechtenstein. On August 1, 2023, we announced an agreement with Neuraxpharm, a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the Ex-US commercialization of BRIUMVI.
With this approval, the centralized marketing authorization is valid in all EU member states, Iceland, Norway and Liechtenstein. On August 1, 2023, we entered into a Commercialization Agreement with Neuraxpharm, a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the ex-US commercialization of BRIUMVI.
Further, our breach of an existing license or failure to obtain a license to technology required to commercialize our products may seriously harm our business. We also may need to commence litigation to enforce any patents issued to us or to determine the scope and validity of third-party proprietary rights.
Further, our breach of an existing license or failure to obtain a license to technology required to commercialize our products may seriously harm our business. We also may need to commence litigation to enforce any patents issued to us or to determine the scope and validity of third-party proprietary rights. Litigation would involve substantial costs.
Applications are pending in other jurisdictions. ​ TG-1801 (anti-CD47/anti-CD19 bispecific antibody) ​ Pursuant to our joint venture and license option agreement with Novimmune SA (Novimmune), we maintain an exclusive option, exercisable at specific times during development, to license the commercial rights to a series of global patent applications and patents, and the non-exclusive right to certain technology patent applications.
TG-1801 (anti-CD47/anti-CD19 bispecific antibody) Pursuant to our joint venture and license option agreement with Novimmune SA (Novimmune), we maintain an exclusive option, exercisable at specific times during development, to license the commercial rights to a series of global patent applications and patents, and the non-exclusive right to certain technology patent applications.
Therefore, in light of the SEC’s guidance, we encourage investors, the media and others interested in us to review the information we post on the U.S. social media channels listed on our website.
Therefore, in light of the SEC’s guidance, we encourage investors, the media and others interested in us to also review the information we post on the social media channels listed on our website.
The following table summarizes the current status for our lead drug candidates as of February 2024.
The following table summarizes the current status for our lead drug candidates as of February 2025.
For example, the California Consumer Protection Act, (CCPA), which went into effect on January 1, 2020, established a privacy framework for covered businesses by creating an expanded definition of personal information, data privacy rights for consumers in California, and a potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches.
For example, the California Consumer Protection Act, (CCPA) established a privacy framework for covered businesses by creating an expanded definition of personal information, data privacy rights for consumers in California, and a potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches.
Furthermore, European data protection authorities may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of processing personal data in or from the European Union or United Kingdom. ​ Human Capital ​ As of February 26, 2024, we had 264 full-time employees.
Furthermore, European data protection authorities may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of processing personal data in or from the European Union or United Kingdom. ​ Human Capital ​ As of February 25, 2025, we had 338 employees.
For example, the Tax Cuts and Jobs Act enacted on December 22, 2017, eliminated the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, commonly referred to as the individual mandate, effective January 1, 2019.
For example, the Tax Cuts and Jobs Act of 2017 eliminated the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, commonly referred to as the individual mandate.
ITEM 1. BUSINESS. OVERVIEW TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell mediated diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the U.S.
ITEM 1. BUSINESS. OVERVIEW TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell mediated diseases. TG has received approval from the U.S.
Our earliest in time patent families relate to compositions of matter for ublituximab , which has been issued in the U.S., Europe and other jurisdictions, including Australia, Canada, China, Japan, Korea and India.
Our earliest in time patent family relates to compositions of matter for ublituximab, which have issued in the U.S., Europe and other jurisdictions, including Australia, Canada, China, Japan, Korea and India.
On November 1, 2023, we announced that we also received approval by the MHRA for BRIUMVI to treat adult patients with RMS with active disease defined by clinical or imaging features in the UK.
On November 1, 2023, we announced that we also received approval by the MHRA for BRIUMVI to treat adult patients with RMS with active disease defined by clinical or imaging features in the UK. On February 26, 2024, we announced the commercial launch of BRIUMVI in the European Union (EU).
Additional factors that can cause delay or termination of our clinical trials, or that may increase the costs of these trials, include: ​ ● slow patient enrollment due to the nature of the clinical trial plan, the proximity of patients to clinical sites, the eligibility criteria for participation in the study or other factors; ● inadequately trained or insufficient personnel at the study site to assist in overseeing and monitoring clinical trials or delays in approvals from a study site’s review board; ● longer treatment time required to demonstrate efficacy or determine the appropriate product dose; ● insufficient supply of the drug candidates; ● adverse medical events or side effects in treated patients; and ● ineffectiveness of the drug candidates. ​ In December 2022, with the passage of Food and Drug Omnibus Reform Act, Congress required sponsors to develop and submit a diversity action plan (DAP) for each Phase 3 clinical trial or any other “pivotal study” of a new drug or biological product.
Additional factors that can cause delay or termination of our clinical trials, or that may increase the costs of these trials, include: ​ ● slow patient enrollment due to the nature of the clinical trial plan, the proximity of patients to clinical sites, the eligibility criteria for participation in the study or other factors; ● inadequately trained or insufficient personnel at the study site to assist in overseeing and monitoring clinical trials or delays in approvals from a study site’s review board; ● longer treatment time required to demonstrate efficacy or determine the appropriate product dose; ● insufficient supply of the drug candidates; ● adverse medical events or side effects in treated patients; and ● ineffectiveness of the drug candidates.
The total deal is valued at up to $645 million in upfront and milestone payments. In addition, we will receive tiered double-digit royalties on net product sales up to 30%.
We are eligible to receive up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones. The total deal is valued at up to $645 million in upfront and milestone payments. In addition, we will receive tiered double-digit royalties on net product sales up to 30%.
Pursuant to such license Agreement, the Company made an upfront payment to Precision of $7.5 million, consisting of (i) $5.25 million in cash and (ii) $2.25 million as an equity investment. The Company will make an additional deferred payment of $2.5 million to Precision as an equity investment to Precision within 12 months at a pre-specified premium.
Pursuant to such license Agreement, the Company made an upfront payment to Precision of $7.5 million, consisting of (i) $5.25 million in cash and (ii) $2.25 million as an equity investment. The Company made an additional payment of $2.5 million as an equity investment to Precision in January 2025.
Our most recently filed patent family relates to compositions of matter comprising ublituximab, methods of manufacturing those compositions and methods for treating multiple sclerosis using those compositions. This family includes three issued U.S. patents and one recently allowed U.S. application. We also have patent applications pending in this family in the U.S., Argentina, the EU and Taiwan.
Our most recently filed patent family relates to compositions of matter comprising ublituximab, methods of manufacturing those compositions and methods for treating multiple sclerosis using those compositions. This family includes four issued U.S. patents and two pending U.S. applications.
Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our product candidates, proprietary information and proprietary technology through a combination of contractual arrangements and patents, both in the U.S. and elsewhere in the world. ​ We also depend upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of our advisors, consultants and other contractors.
Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our product candidates, proprietary information and proprietary technology through a combination of contractual arrangements and patents, both in the U.S. and elsewhere in the world.
In addition, either party may terminate the agreement upon a material breach, after providing the other party with adequate notice and allowing 45 days to cure. ​ 11 Table of Contents TG-1801 (anti-CD47/anti-CD19 bispecific antibody) ​ In June 2018, we entered into a Joint Venture and License Option Agreement with Novimmune to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG 1801 (previously NI 1701).
TG-1801 (anti-CD47/anti-CD19 bispecific antibody) In June 2018, we entered into a Joint Venture and License Option Agreement with Novimmune to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG 1801 (previously NI 1701).
Results from the ULTIMATE I & II trials were published in August 2022 in The New England Journal of Medicine. On January 26, 2023, we announced the commercial launch of BRIUMVI, making it available to physicians and patients.
Results from the ULTIMATE I & II trials were published in August 2022 in The New England Journal of Medicine. We commercially launched BRIUMVI in the U.S. on January 26, 2023, making it available to physicians and patients. In August 2023, we entered into a commercialization agreement (the Commercialization Agreement) with Neuraxpharm Pharmaceuticals, S.L.
On July 1, 2023, the permanent J-Code for BRIUMVI (J2329) became effective. Ex-U.S. Commercialization of BRIUMVI On June 1, 2023, we announced that the EC granted approval of BRIUMVI for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features.
In January 26, 2023, we announced the U.S. commercial launch of BRIUMVI, making it available to physicians and patients. Ex-U.S. Commercialization of BRIUMVI On June 1, 2023, we announced that the EC granted approval of BRIUMVI for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features.
Additionally, proof that a competitor contributes to or induces infringement of a patented method of use by another can also prove difficult because an off-label use of a product could prohibit a finding of contributory infringement, and inducement of infringement requires proof of intent by the competitor. 10 Table of Contents LICENSING AGREEMENTS AND COLLABORATIONS ​ We have formed strategic alliances with a number of companies for the manufacture and commercialization of our products.
Additionally, proof that a competitor contributes to or induces infringement of a patented method of use by another can also prove difficult because an off-label use of a product could prohibit a finding of contributory infringement, and inducement of infringement requires proof of intent by the competitor.
The license will terminate on a country-by-country basis upon the expiration of the last licensed patent right or any other exclusivity right in such country, unless the agreement is earlier terminated (i) by us for any reason, or (ii) by either party due to a breach of the agreement. ​ Cosibelimab ​ In March 2015, we entered into a global collaboration (the Collaboration Agreement) with Checkpoint Therapeutics, Inc.
The license will terminate on a country-by-country basis upon the expiration of the last licensed patent right or any other exclusivity right in such country, unless the agreement is earlier terminated (i) by us for any reason, or (ii) by either party due to a breach of the agreement. ​ 14 Table of Contents COMPETITION ​ Competition in the pharmaceutical and biotechnology industries is intense.
LFB Group is eligible to receive future payments of approximately $6.0 million, upon our successful achievement of certain regulatory milestones, in addition to royalty payments on net sales of ublituximab at a royalty rate in the high-single digits.
LFB Group is eligible to receive royalty payments on net sales of ublituximab at a royalty rate in the high-single digits.
The Company and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for the Company to license the rights to TG 1801, in which case Novimmune is eligible to receive additional milestone payments totaling approximately $185 million as well as tiered royalties on net sales in the high single to low double digits upon and subject to the achievement of certain milestones. ​ Azer-Cel (allogeneic CD19 CAR T) In January 2024, we, through our wholly-owned subsidiary, TG Cell Therapy, Inc., entered into a global exclusive license agreement with Precision to develop and commercialize azer-cel for autoimmune diseases and all other non-oncology indications.
The Company and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for the Company to license the rights to TG 1801, in which case Novimmune is eligible to receive additional milestone payments totaling approximately $185 million as well as tiered royalties on net sales in the high single to low double digits upon and subject to the achievement of certain milestones.
Commercialization of BRIUMVI (ublituximab-xiiy) ​ On December 28, 2022, we announced the FDA approval of BRIUMVI (ublituximab-xiiy) for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, primarily based on results from the ULTIMATE I & II Phase 3 trials, and on January 26, 2023, we announced the U.S. commercial launch of BRIUMVI, making it available to physicians and patients.
Commercialization of BRIUMVI (ublituximab-xiiy) ​ On December 28, 2022, BRIUMVI received approval by the FDA for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease based on results from the ULTIMATE I & II Phase 3 trials.
B-cell receptor (BCR) signaling is crucial for normal B-cell development and supports the survival and growth of B-cells. We are currently evaluating TG-1701 in a Phase 1, multi-center, dose-escalation clinical trial in patients with B-cell malignancies. Data from this trial was last presented at the 2021 American Society of Hematology (ASH) annual meeting.
B-cell receptor (BCR) signaling is crucial for normal B-cell development and supports the survival and growth of B-cells. We evaluated TG-1701 in a Phase 1, multi-center, dose-escalation clinical trial in patients with B-cell malignancies, which is now closed.
(Precision) to acquire a worldwide license to Precision’s Azercabtagene Zapreleucel (azer-cel), an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications.
Pipeline Expansion and Development On January 9, 2024, we entered into an agreement with Precision BioSciences, Inc. (Precision) to acquire a worldwide license to Precision’s Azercabtagene Zapreleucel (azer-cel), an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications. Azer-cel is an allogeneic (off the shelf) CAR T program.
Approval was granted for this indication based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions.
BRIUMVI received approval by the FDA on December 28, 2022 for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions.
UKONIQ (umbralisib) ​ In September 2014, we exercised our option to license the global rights to umbralisib, thereby entering into an exclusive licensing agreement (the Umbralisib License) with Rhizen Pharmaceuticals, S A (Rhizen) for the development and commercialization of umbralisib. Rhizen is eligible to receive approval and sales-based milestone payments in the aggregate of approximately $175 million.
The Company has also agreed to make certain payments to Precision’s licensors during the term of our license agreement with Precision. UKONIQ (umbralisib) In September 2014, we exercised our option to license the global rights to umbralisib, thereby entering into an exclusive licensing agreement (the Umbralisib License) with Rhizen Pharmaceuticals, S A (Rhizen) for the development and commercialization of umbralisib.
Additionally, Rhizen receives tiered royalties that escalate from high single digits to low double digits on any net sales of umbralisib.
Rhizen is eligible to receive approval and sales-based milestone payments in the aggregate of approximately $175 million. Additionally, Rhizen receives tiered royalties that escalate from high single digits to low double digits on any net sales of umbralisib.
Azercabtagene Zapreleucel (azer-cel) Azer-cel is an allogeneic (off-the-shelf) CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications. Made from donor-derived T cells modified using a proprietary ARCUS genome editing technology, azer-cel recognizes the well characterized B-cell surface protein CD19, an important and validated target in several B-cell cancers and autoimmune diseases.
Made from donor-derived T cells modified using a proprietary ARCUS genome editing technology, azer-cel recognizes the well characterized B-cell surface protein CD19, an important and validated target in several B-cell cancers and autoimmune diseases. Azer-cel is designed to avoid graft-versus-host disease (GvHD), a significant complication associated with other donor-derived, cell-based therapies.
The primary endpoint for each study was ARR following 96 weeks of treatment. This program was led by Lawrence Steinman, MD, George A. Zimmermann Professor and Professor of Pediatrics, Neurology and Neurological Sciences at Stanford University. In December 2020, we announced positive topline results from the ULTIMATE I & II trials.
The primary endpoint for each study was ARR following 96 weeks of treatment. In December 2020, we announced positive topline results from the ULTIMATE I & II trials.
Under the terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab.
Under the terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab. As of December 31, 2024, we have incurred expenses of approximately $31.0 million related to milestones in accordance with the terms of the LFB License Agreement.
During this 12 year period a biosimilar product that references our BRIUMVI product, cannot be approved. ​ TG-1701 (BTK inhibitor) ​ Pursuant to our license agreement with Jiangsu Hengrui Medicine Co.
In the U.S., the Biologics Price Competition and Innovation Act provides that BRIUMVI is eligible for 12 years of market exclusivity from the date of BRIUMVI’s U.S. approval. During this 12-year period a biosimilar product that references our BRIUMVI product cannot be approved. ​ TG-1701 (BTK inhibitor) ​ Pursuant to our license agreement with Jiangsu Hengrui Medicine Co.
The objectives of the BPCIA are conceptually similar to those of the Hatch-Waxman Act described above. The implementation of an abbreviated approval pathway for biosimilar products is under the direction of the FDA.
The objectives of the BPCIA are conceptually similar to those of the Hatch-Waxman Act. The implementation of an abbreviated approval pathway for biosimilar products is under the direction of the FDA. Since the enactment of the BPCIA, the FDA has issued guidance on biosimilars, addressing scientific, quality and procedural issues relevant to an abbreviated application for a biosimilar product.
Litigation would involve substantial costs. ​ 8 Table of Contents Moreover, physicians may prescribe such a competitive identical product for indications other than the one for which the product has been approved, or off-label indications, that are covered by the applicable patents.
Moreover, physicians may prescribe such a competitive identical product for indications other than the one for which the product has been approved, or off-label indications, that are covered by the applicable patents. Although such off-label prescriptions may directly infringe or contribute to or induce infringement of method of use patents, such infringement is difficult to prevent or prosecute. U.S.
Clinical Drug Candidate: (molecular target) Initial Target Disease Stage of Development (trial name) Ublituximab (anti-CD20 mAb) Relapsing Forms of Multiple Sclerosis (RMS) APPROVED TG-1701 (BTK inhibitor) B-cell disorders Phase 1 trial TG-1801 (anti-CD47/CD19 bispecific mAb) B-cell disorders Phase 1 trial Azer-cel Auto-immune disorders Phase 1 (pending) ​BRIUMVI (ublituximab-xiiy) Overview BRIUMVI is the first and only anti-CD20 monoclonal antibody approved for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, that can be administered in a twice a year one-hour infusion following the starting dose.
Clinical Drug Candidate: (molecular target) Initial Target Disease Stage of Development Ublituximab IV (anti-CD20 mAb) RMS APPROVED Ublituximab Subcutaneous (anti-CD20 mAb) RMS Phase 1 trial Azer-cel Auto-immune disorders Phase 1 ​BRIUMVI (ublituximab-xiiy) Overview BRIUMVI is an anti-CD20 monoclonal antibody that can be administered to adults with RMS in a one-hour infusion every 24 weeks, following the starting dose.
This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial. ​ 9 Table of Contents We, or those companies from which we have licensed our drug candidates, file patent applications directed to our drug candidates in an effort to establish intellectual property positions regarding these new chemical entities as well as uses of these new chemical entities in the treatment of diseases.
This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial.
Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 per year (or up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission.
Failure to submit required information may result in civil monetary penalties for payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission. Drug manufacturers are required to submit annual reports to the Centers for Medicare & Medicaid Services (CMS), which publicly posts the data on its website.
Multiple Sclerosis Overview RMS is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses.
Examples of common and very debilitating autoimmune disorders for which abnormally functioning B-cells have been implicated include multiple sclerosis (MS) and rheumatoid arthritis (RA). ​The Company’s current focus is on MS. 6 Table of Contents Multiple Sclerosis Overview RMS is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses.
HIPAA, as amended by the Health Information Technology and Clinical Health Act, (HITECH), and their respective implementing regulations, including the final omnibus rule published on January 25, 2013, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information.
We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology and Clinical Health Act, (HITECH), and their respective implementing regulations, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information.
Neuraxpharm In August 2023, we entered into an agreement with Neuraxpharm, for the ex-U.S. commercialization of BRIUMVI.
Neuraxpharm In August 2023, we entered into a Commercialization Agreement with Neuraxpharm, for the ex-U.S. commercialization of BRIUMVI. Under the terms of the Commercialization Agreement, we received an upfront payment of $140 million and an additional $12.5 million upon launch in the first EU country.
We or Hengrui may terminate the agreement upon notice to the other upon breach without remedy or upon insolvency.
We or Hengrui may terminate the agreement upon notice to the other upon breach without remedy or upon insolvency. In addition, either party may terminate the agreement upon a material breach, after providing the other party with adequate notice and allowing 45 days to cure.
Launch of BRIUMVI On December 28, 2022, we announced that the FDA granted approval of ublituximab, now referred to as BRIUMVI, for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
BRIUMVI received approval by the FDA on December 28, 2022 for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease based on results from the ULTIMATE I & II Phase 3 trials.
Since the enactment of the BPCIA, the FDA has issued guidance on biosimilars, addressing scientific, quality and procedural issues relevant to an abbreviated application for a biosimilar product. As of December 2022, the FDA had approved 40 biosimilar products. ​ Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms.
As of December 2024, the FDA had approved 60 biosimilar products. ​ Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms.
BRIUMVI is an anti-CD20 monoclonal antibody approved for patients with RMS that can be administered in a one-hour infusion following the starting dose.
We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities. Business Highlights Commercialization of BRIUMVI BRIUMVI is an anti-CD20 monoclonal antibody that can be administered to adults with RMS in a one-hour infusion every 24 weeks, following the starting dose.
Certain states also mandate implementation of compliance programs, impose restrictions on drug manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians. ​ We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.
These reporting obligations include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners. Certain states also mandate implementation of compliance programs, impose restrictions on drug manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians.
ENHANCE Phase 3b Trial: On October 11, 2023, we presented the first data from the ENHANCE Phase 3b trial evaluating BRIUMVI in patients with RMS who switch from another anti-CD20 therapy to BRIUMVI. The presentation occurred at the 2023 European Committee for Treatment and Research in Multiple Sclerosis Annual Meeting.
In September 2024 we presented new five-year data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with RMS, at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting.
Azer-cel is an allogeneic (off the shelf) CAR T program, and the Company has near term plans to evaluate the program in multiple autoimmune indications. ​ 5 Table of Contents ​ CORPORATE INFORMATION We were incorporated in Delaware in 1993. Our executive offices are located at 3020 Carrington Mill Blvd, Suite 475, Morrisville, North Carolina, 27560.
In January 2025, we announced the first patients with myasthenia gravis (MG) have been enrolled in a clinical trial evaluating ublituximab. 5 Table of Contents ​ CORPORATE INFORMATION We were incorporated in Delaware in 1993. Our executive offices are located at 3020 Carrington Mill Blvd, Suite 475, Morrisville, North Carolina, 27560.
On February 26, 2024, we announced the commercial launch of BRIUMVI in the European Union (EU) by Neuraxpharm, with BRIUMVI made available for commercial sale in Germany, with additional EU markets expected to follow. 7 Table of Contents TG-1701 (BTK inhibitor) Overview TG-1701 is a novel, orally available and covalently-bound Bruton’s tyrosine kinase (BTK) inhibitor that exhibits strong selectivity to BTK in in vitro kinase screening.
Morgan Healthcare Conference we announced our plans to commence a pivotal program in 2025 evaluating subcutaneous ublituximab with an expected dosing frequency of at least every other month. TG-1701 (BTK inhibitor) Overview TG-1701 is a novel, orally available and covalently-bound Bruton’s tyrosine kinase (BTK) inhibitor that exhibits strong selectivity to BTK in in vitro kinase screening.
Some of these diseases may not be antibody mediated but may still result from aberrant activity of B-cells. Examples of common and very debilitating autoimmune disorders for which abnormally functioning B-cells have been implicated include multiple sclerosis (MS) and rheumatoid arthritis (RA). ​The Company’s current focus is on MS.
Some of these diseases may not be antibody mediated but may still result from aberrant activity of B-cells.
(Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, for the ex-U.S. commercialization of BRIUMVI. On November 1, 2023, we announced that we also received approval by the MHRA for BRIUMVI to treat adult patients with RMS with active disease defined by clinical or imaging features in the UK.
(Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, for the ex-U.S. commercialization of BRIUMVI. On February 26, 2024, BRIUMVI was first made available in the European market by Neuraxpharm in Germany and is now commercially available in several other countries in the European Union and the United Kingdom.
Removed
We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities. Business Highlights FDA Approval and U.S.
Added
In August 2024, we announced FDA clearance of the Investigational New Drug Application (IND) for azer-cel for the treatment of progressive forms of multiple sclerosis. In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating subcutaneous ublituximab in patients with RMS and in January 2025, at the Annual J.P.
Removed
We are committed to helping patients access BRIUMVI through the BRIUMVI Patient Support Program, which we launched following the approval, additional information can be found at www.briumvi.com. Ex-U.S.
Added
Morgan Healthcare Conference we announced our plans to commence a pivotal program in 2025 evaluating a subcutaneous ublituximab with an expected dosing frequency of at least every other month.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

201 edited+109 added−56 removed405 unchanged
Biggest changeIn addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute or the Federal Food, Drug, and Cosmetic Act (FDCA) constitutes a false or fraudulent claim for purposes of the False Claims Act; ● the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; ● the Physician Payments Sunshine Act under section 6002 of the Affordable Care Act requires manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program to monitor and report certain information related to payments and other transfers of value to and the ownership and investment interests of physicians and certain other healthcare providers as well as teaching hospitals to the federal government for redisclosure to the public; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, which also imposes obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● a wide range of federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers including those related to privacy; ● the FDCA and its implementing regulations, which among other things, strictly regulate drug product marketing and prohibit manufacturers from promotion and marketing of products prior to approval or for uses inconsistent with the FDA-required labeling; ● federal laws, including the Medicaid Drug Rebate Program, that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; ● the Drug Supply Chain Security Act (DSCSA), which imposes obligations on entities in the commercial product supply chain, including manufacturers, to identify and track prescription drugs as they are distributed in the U.S.; and ● state law equivalents of some of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers, state transparency laws, state laws limiting interactions between pharmaceutical manufacturers and members of the healthcare industry, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts. 39 Table of Contents As we continue commercialization of BRIUMVI, we are taking steps to provide patient support services to help patients access the product.
Biggest changeHITECH created new tiers of civil monetary penalties, made civil and criminal penalties directly applicable to business associates, and gave state attorneys authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA laws and seek attorneys’ fees and costs; ● a wide range of federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers including those related to privacy; ● the FDCA and its implementing regulations, which among other things, strictly regulate drug product marketing and prohibit manufacturers from promotion and marketing of products prior to approval or for uses inconsistent with the FDA-required labeling; ● federal laws, including the Medicaid Drug Rebate Program, that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; ● the Drug Supply Chain Security Act (DSCSA), which imposes obligations on entities in the commercial product supply chain, including manufacturers, to identify and track prescription drugs as they are distributed in the U.S.; and ● state law equivalents of some of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers, state transparency laws, state laws limiting interactions between pharmaceutical manufacturers and members of the healthcare industry, marketing restrictions and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.
If we are required to repeat or conduct additional clinical trials or other testing of our drug candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our drug candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may: ● be delayed in obtaining marketing approval for our product candidates; ● not obtain marketing approval at all; ● obtain marketing approval in some countries and not others; ● obtain approval for indications or patient populations that are not as broad as intended or desired; ● be subject to post-marketing requirements or post-marketing commitments; ● be subject to increased pricing pressure; or ● have the drug removed from the market after obtaining marketing approval.
If we are required to repeat or conduct additional clinical trials or other testing of our drug candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our drug candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may: ● be delayed in obtaining marketing approval for our product candidates; ● not obtain marketing approval at all; ● obtain marketing approval in some countries and not others; ● obtain marketing approval for indications or patient populations that are not as broad as intended or desired; ● be subject to post-marketing requirements or post-marketing commitments; ● be subject to increased pricing pressure; or ● have the drug removed from the market after obtaining marketing approval.
To the extent possible and commercially practicable, we plan to develop back-up strategies for raw materials, manufacturing and testing services for our commercial products.
To the extent possible and commercially practicable, we plan to develop back-up strategies for raw materials and manufacturing and testing services for our commercial products.
The amount and timing of our future funding requirements will depend on many factors, including, but not limited to, the following: ● the success of the commercialization of BRIUMVI and any other products for which we receive regulatory approval; ● the costs and timing of clinical and commercial manufacturing supply arrangements for each product and product candidate; ● the costs of expanding our sales, distribution, and other commercialization capabilities; ● the costs and timing of regulatory approvals; ● the progress of our clinical trials, including expenses to support the trials and milestone payments that may become payable under our license agreements; ● our ability to establish and maintain strategic collaborations, including licensing and other arrangements; ● the costs involved in enforcing or defending patent claims or other intellectual property rights; and ● the extent to which we in-license or invest in other indications or product candidates.
The amount and timing of our future funding requirements will depend on many factors, including, but not limited to, the following: ● the timing and success of the ongoing commercialization of BRIUMVI and any other products for which we receive regulatory approval; ● the costs and timing of clinical and commercial manufacturing supply arrangements for each product and product candidate; ● the costs of expanding our sales, distribution, and other commercialization capabilities; ● the costs and timing of regulatory approvals; ● the progress of our clinical trials, including expenses to support the trials and milestone payments that may become payable under our license agreements; ● our ability to establish and maintain strategic collaborations, including licensing and other arrangements; ● the costs involved in enforcing or defending patent claims or other intellectual property rights; and ● the extent to which we in-license or invest in other indications or product candidates.
In addition to the Commercialization Agreement, we may enter into collaboration arrangements with other collaboration and commercialization partners. 44 Table of Contents We are subject to a number of risks associated with our dependence on our relationships with our collaboration and commercialization partners, including: ● our collaboration and commercialization partners may terminate their collaboration or commercialization agreements with us for reasons specified in the collaboration or commercialization agreements, including our breach; ● the need for us to identify and secure on commercially reasonable terms the services of third parties to perform key activities, including development and commercialization activities, currently performed by our collaboration or commercialization partners in the event that a collaboration or commercialization partner terminates its agreement with us; ● adverse decisions by a collaboration or commercialization partner regarding the amount and timing of resource expenditures for the commercialization, distribution, and sale of our drug products; ● failure by a collaboration or commercialization partner to perform its duties under its agreement with us (e.g., its failure to comply with regulatory requirements which may disrupt its performance of its obligations under the agreement with us); ● failure by a collaboration or commercialization partner to timely deliver accurate and complete financial information to us or to maintain adequate and effective internal control over its financial reporting may negatively affect our ability to meet our financial reporting obligations as required by the SEC; ● failure by a collaboration or commercialization partner to timely deliver accurate and complete medical or clinical information to us or to maintain adequate and effective internal control over its pharmacovigilance activities and reporting may negatively affect our ability to meet our reporting obligations as required by the FDA and other regulatory bodies; ● collaboration or commercialization partners’ and their affiliates’ development and commercialization of products that compete directly or indirectly with our products or product candidates; ● decisions by a collaboration or commercialization partner to prioritize others of its current or future products more highly than our drug products or our product candidates when it performs its duties; ● possible disagreements with a collaboration or commercialization partner as to the timing, nature and extent of our development plans or distribution and sales and marketing plans; and ● the financial returns to us, if any, under our collaboration agreement with Neuraxpharm depends in large part on the achievement of milestones and generation of product sales, and if Neuraxpharm fails to perform or satisfy its obligations under the collaboration agreements, the development and commercialization of our drug products could be delayed, hindered or may not occur, and our business and prospects could be materially and adversely affected.
In addition to the Commercialization Agreement, we may enter into collaboration arrangements with other collaboration and commercialization partners. 55 Table of Contents We are subject to a number of risks associated with our dependence on our relationships with our collaboration and commercialization partners, including: ● decisions by our collaboration and commercialization partners to terminate their collaboration or commercialization agreements with us for reasons specified in the collaboration or commercialization agreements, including our breach; ● the need for us to identify and secure on commercially reasonable terms the services of third parties to perform key activities, including development and commercialization activities, currently performed by our collaboration or commercialization partners in the event that a collaboration or commercialization partner terminates its agreement with us; ● adverse decisions by a collaboration or commercialization partner regarding the amount and timing of resource expenditures for the commercialization, distribution, and sale of our drug products; ● failure by a collaboration or commercialization partner to perform its duties under its agreement with us (e.g., its failure to comply with regulatory requirements which may disrupt its performance of its obligations under the agreement with us); ● failure by a collaboration or commercialization partner to timely deliver accurate and complete financial information to us or to maintain adequate and effective internal control over its financial reporting may negatively affect our ability to meet our financial reporting obligations as required by the SEC; ● failure by a collaboration or commercialization partner to timely deliver accurate and complete medical or clinical information to us or to maintain adequate and effective internal control over its pharmacovigilance activities and reporting may negatively affect our ability to meet our reporting obligations as required by the FDA and other regulatory bodies; ● collaboration or commercialization partners’ and their affiliates’ development and commercialization of products that compete directly or indirectly with our products or product candidates; ● decisions by a collaboration or commercialization partner to prioritize others of its current or future products more highly than our drug products or our product candidates when it performs its duties; ● possible disagreements with a collaboration or commercialization partner as to the timing, nature and extent of our development plans or distribution and sales and marketing plans; and ● the fact that financial returns to us, if any, under our collaboration agreement with Neuraxpharm depends in large part on the achievement of milestones and generation of product sales, and if Neuraxpharm fails to perform or satisfy its obligations under the collaboration agreements, the development and commercialization of our drug products could be delayed, hindered or may not occur, and our business and prospects could be materially and adversely affected.
Both of these occurrences would be beyond our control. We expect to similarly rely on contract manufacturing relationships for our development programs and any products that we may in-license or acquire in the future. However, there can be no assurance that we will be able to successfully contract with such manufacturers on terms acceptable to us, or at all.
All of these occurrences would be beyond our control. We expect to similarly rely on contract manufacturing relationships for our development programs and any products that we may in-license or acquire in the future. However, there can be no assurance that we will be able to successfully contract with such manufacturers on terms acceptable to us, or at all.
In addition, as patients continue on therapy, there can be no assurance given that the final safety data from studies, once fully analyzed, will be consistent with prior safety data presented, will be differentiated from other similar agents in the same class, will support continued development, or will be favorable enough to support regulatory approvals for the indications studied.
In addition, as patients continue on therapy, there can be no assurance that the final safety data from studies, once fully analyzed, will be consistent with prior safety data presented, will be differentiated from other similar agents in the same class, will support continued development, or will be favorable enough to support regulatory approvals for the indications studied.
Even if rolling review is allowed, there is no guarantee that the FDA will have commenced or completed review of the BLA or NDA modules submitted earlier in the rolling review process. Neither Breakthrough Therapy nor Fast Track designation guarantees Priority Review of an NDA or BLA application. We may seek orphan drug designation for some of our drug candidates.
Even if rolling review is allowed, there is no guarantee that the FDA will have commenced or completed review of the BLA or NDA modules submitted earlier in the rolling review process. Neither Breakthrough Therapy nor Fast Track designation guarantees Priority Review of an NDA or BLA. We may seek orphan drug designation for some of our drug candidates.
Although we believe our estimates are reasonable, many factors may limit their accuracy. For example, the sources we use to make the estimates may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases and the number of patients may turn out to be lower than expected.
Although we believe our estimates are reasonable, many factors may limit their accuracy. For example, the sources we use to make the estimates may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases and the number of patients affected may turn out to be lower than expected.
As BRIUMVI or any future approved products are used more widely or for a longer duration after being brought to market, data may emerge from clinical studies, including confirmatory or other post-marketing studies, or from adverse event reporting, that may affect the commercial potential of our products.
As BRIUMVI or any future approved products are used more widely or for a longer duration after being brought to market, data may emerge from clinical studies, including confirmatory or other post-marketing studies, or from adverse event reporting or pharmacovigilance, that may affect the commercial potential of our products.
In the United States, we are not permitted to market a product candidate until we receive approval of a BLA or NDA from the FDA. The process of obtaining a BLA or NDA approval is expensive, often takes many years, and can vary substantially based upon the type, complexity and novelty of the products involved.
In the United States, we are not permitted to market a new product candidate until we receive approval of a BLA or NDA from the FDA. The process of obtaining a BLA or NDA approval is expensive, often takes many years, and can vary substantially based upon the type, complexity and novelty of the products involved.
In addition, this concentration of ownership might adversely affect the market price of our common stock by: ● delaying, deferring or preventing a change of control of us; ● impeding a merger, consolidation, takeover or other business combination involving us; or ● discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us. 53 Table of Contents Our internal information technology systems, or those of our third-party CROs, CMOs, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug candidates ’ development programs and our commercialization of any products for which we receive regulatory approval.
In addition, this concentration of ownership might adversely affect the market price of our common stock by: ● delaying, deferring or preventing a change of control of us; ● impeding a merger, consolidation, takeover or other business combination involving us; or ● discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us. 66 Table of Contents Our internal information technology systems, or those of our third-party CROs, CMOs, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug candidates ’ development programs and our commercialization of any products for which we receive regulatory approval.
In addition, larger scale Phase 3 studies, which are often conducted internationally, are inherently subject to increased operational risks compared to earlier stage studies, including the risk that the results could vary on a region to region or country to country basis, which could materially adversely affect the outcome of the study or the opinion of the validity of the study results by applicable regulatory agencies. ​ 29 Table of Contents From time to time, we may publicly disclose top-line or preliminary data from our clinical trials, which is based on a preliminary analysis of available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.
In addition, larger scale Phase 3 studies, which are often conducted internationally, are inherently subject to increased operational risks compared to earlier stage studies, including the risk that the results could vary on a region to region or country to country basis, which could materially adversely affect the outcome of the study or the opinion of the validity of the study results by applicable regulatory agencies. ​ 34 Table of Contents From time to time, we may publicly disclose top-line or preliminary data from our clinical trials, which is based on a preliminary analysis of available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.
We also make assumptions, estimations, calculations and conclusions as part of our analyses of such data, and we may not have received or had the opportunity to fully and carefully evaluate all data from the particular study or trial, including all endpoints and safety data.
We also make assumptions, estimations, calculations and conclusions as part of our analyses of such data, and we may not have received or had the opportunity to fully and carefully evaluate all data, such as later data, from the particular study or trial, including all endpoints and safety data.
Similarly, following each round of process improvements, if any, for any of our drug candidates, future clinical trial results conducted with the new material will be subject to uncertainty related to the effects, if any, of those additional process improvements that were made. 36 Table of Contents Risks Related to Governmental Regulation of Pharmaceutical Industry and Legal Compliance Matters We are subject to new legislation, regulatory proposals and third-party payor initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital.
Similarly, following each round of process improvements, if any, for any of our drug candidates, future clinical trial results conducted with the new material will be subject to uncertainty related to the effects, if any, of those additional process improvements that were made. 42 Table of Contents Risks Related to Governmental Regulation of Pharmaceutical Industry and Legal Compliance Matters We are subject to new legislation, regulatory proposals and third-party payor initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital.
Furthermore, if we obtain regulatory approval for a product or product candidate in a foreign jurisdiction, we will be subject to the burden of complying with complex regulatory, legal, and other requirements that could be costly and could subject us to additional risks and uncertainties. 35 Table of Contents We have product candidates still under development and are also engaging manufacturing partners in commercial manufacturing activities, and as such clinical and commercial manufacturing site additions and process improvements implemented in the production of our product and product candidates may affect their timely delivery or quality.
Furthermore, if we obtain regulatory approval for a product or product candidate in a foreign jurisdiction, we will be subject to the burden of complying with complex regulatory, legal, and other requirements that could be costly and could subject us to additional risks and uncertainties. 41 Table of Contents We have product candidates still under development and are also engaging manufacturing partners in commercial manufacturing activities, and as such clinical and commercial manufacturing site additions and process improvements implemented in the production of our product and product candidates may affect their timely delivery or quality.
Accordingly, no assurance can be made that a safe and efficacious dose can be found for these compounds or that they will ever enter into advanced clinical trials alone or in combination with other product candidates.
Accordingly, no assurance can be made that a safe and efficacious dose can be found for these compounds or that they will ever enter into advanced or pivotal clinical trials alone or in combination with other product candidates.
Additional factors that may inhibit our efforts to commercialize BRIUMVI and our other product candidates on our own, or through partnership, and generate product revenues include: ● the costs and time associated with the initial and ongoing training of commercialization personnel on the applicable disease states, products, competitors, and legal and regulatory compliance matters; ● the inability of commercialization personnel to obtain access to physicians or to effectively promote or provide education about BRIUMVI and any future approved products; ● the lack of complementary drugs to be offered by the Company, which may put us at a competitive disadvantage relative to companies with more extensive product lines; ● decisions by third-party payors to deny reimbursement of or delay coverage decisions regarding BRIUMVI or following approval of any product candidates; ● our inability to maintain a healthcare compliance program including effective mechanisms for compliance monitoring; ● our inability to establish and maintain commercial partnerships outside the U.S.; ● our inability, or the inability of a third party with whom we have partnered, to maintain the necessary regulatory approvals required to operate in markets outside of the U.S.; ● the timing of product availability for commercial sale following approval and continued product supply; and ● unforeseen costs and expenses associated with creating a commercialization organization. 24 Table of Contents In addition, we have entered into a commercialization agreement, and may enter into additional agreements in the future, that facilitate commercialization of BRIUMVI and/or future products that receive approval in markets outside the U.S. through partnerships.
Additional factors that may inhibit our efforts to support the ongoing commercialization of BRIUMVI and our other product candidates on our own, or through partnership, and generate product revenues include: ● the costs and time associated with the initial and ongoing training of commercialization personnel on the applicable disease states, products, competitors, and legal and regulatory compliance matters; ● the inability of commercialization personnel to obtain access to physicians or to effectively promote or provide education about BRIUMVI and any future approved products; ● the lack of complementary drugs to be offered by the Company, which may put us at a competitive disadvantage relative to companies with more extensive product lines; ● decisions by third-party payors to deny reimbursement of or delay coverage decisions regarding BRIUMVI or following approval of any product candidates; ● our inability to maintain a healthcare compliance program including effective mechanisms for compliance monitoring; ● our inability to establish and maintain commercial partnerships outside the U.S.; ● our inability, or the inability of a third party with whom we have partnered, to maintain the necessary regulatory approvals required to operate in markets outside of the U.S.; ● the timing of product availability for commercial sale following approval and continued product supply; and ● unforeseen costs and expenses associated with creating a commercialization organization. 28 Table of Contents In addition, we have entered into a Commercialization Agreement, and may enter into additional agreements in the future, that facilitate commercialization of BRIUMVI and/or future products that receive approval in markets outside the U.S. through partnerships.
Our reliance on third parties increases the risk that we will not have sufficient quantities of our products or product candidates or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts. 42 Table of Contents The facilities used by contract manufacturers to manufacture, test, package, and label our product and product candidates typically undergo periodic inspections by the FDA or a comparable foreign regulatory authority to verify compliance with applicable cGMP regulations.
Our reliance on third parties increases the risk that we will not have sufficient quantities of our products or product candidates or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts. 52 Table of Contents The facilities used by contract manufacturers to manufacture, test, package, and label our product and product candidates typically undergo periodic inspections by the FDA or a comparable foreign regulatory authority to verify compliance with applicable cGMP regulations.
Even if the DSMB finds no safety concerns and recommends no modifications to the ongoing study, this does not mean the safety profile reported in the study may support a marketing approval or commercial acceptance if marketing approval is granted.
Even if the IRB or DSMB finds no safety concerns and recommends no modifications to the ongoing study, this does not mean the safety profile reported in the study may support a marketing approval or commercial acceptance if marketing approval is granted.
The success of our development programs and achievement of regulatory approval of our product candidates will depend on several factors, including, among others, the following: ● successful completion of our clinical programs with positive results that support a finding of effectiveness and an acceptable safety profile of our product candidates in the intended populations within the timeframes we have projected; ● Investigational New Drugs (INDs) and clinical trial applications (CTAs), being cleared/approved such that our product candidates can commence clinical trials; ● successful initiation and completion of preclinical studies and successful initiation of, enrollment in, and completion of clinical trials; ● sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; ● receipt of regulatory approvals from applicable regulatory authorities for our product candidates; ● establishing commercially viable arrangements with third-party manufacturers for clinical supply and commercial manufacturing; and ● obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates.
The success of our development programs and achievement of regulatory approval of our product candidates will depend on several factors, including, among others, the following: ● successful completion of our clinical programs with positive results that support a finding of effectiveness and an acceptable safety profile of our product candidates in the intended populations within the timeframes we have projected; ● Investigational New Drug Applications (INDs) and clinical trial applications (CTAs), being cleared/issued/approved such that our product candidates can commence clinical trials; ● successful initiation and completion of preclinical studies and successful initiation of, enrollment in, and completion of clinical trials; ● sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; ● receipt of regulatory approvals from applicable regulatory authorities for our product candidates; ● establishing commercially viable arrangements with third-party manufacturers for clinical supply and commercial manufacturing; and ● obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates.
With the FDA and EMA approval of BRIUMVI, we are subject to additional extensive healthcare statutory and regulatory requirements and oversight by the federal government and the states and foreign governments in which we conduct our business.
With the FDA, EMA and MHRA approval of BRIUMVI, we are subject to additional extensive healthcare statutory and regulatory requirements and oversight by the federal government and the states and foreign governments in which we conduct our business.
If we sought to find one or more other pharmaceutical company partners for some or all of these activities, we may not be successful in such efforts, or they may result in collaborations that have us expending greater funds and efforts than our relationships with our current collaboration and commercialization partners. 45 Table of Contents We may seek to establish additional collaborations, and if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
If we sought to find one or more other pharmaceutical company partners for some or all of these activities, we may not be successful in such efforts, or they may result in collaborations that have us expending greater funds and efforts than our relationships with our current collaboration and commercialization partners. 56 Table of Contents We may seek to establish additional collaborations, and if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
We are also continuing to generate additional clinical data for BRIUMVI to support and potentially expand commercial adoption, including assessing long-term tolerability in an Open-Label Extension of the Phase 3 ULTIMATE I and II trials and Phase 4 clinical studies necessary to satisfy post-approval commitments for regulatory authorities or those undertaken voluntarily by the Company to evaluate the use of BRIUMVI in alternate settings or with alternate methods of administration.
We are also continuing to generate additional clinical data for BRIUMVI to support and potentially expand commercial adoption, including assessing long-term tolerability in our Open-Label Extension of the Phase 3 ULTIMATE I and II trials and Phase 4 clinical studies necessary to satisfy post-approval commitments for regulatory authorities or those undertaken voluntarily by the Company to evaluate the use of BRIUMVI in alternate settings or with alternate methods of administration.
In a competitive environment, a company’s communications may also be subject to heightened scrutiny from regulators and competitors, under laws, regulations, and guidance about promotional communications (advertising and promotional labeling) and non-promotional communications (e.g., certain educational and scientific exchange); and with regard to potential competitor actions under federal law (the Lanham Act) and congruous state law, which protect businesses against the unfair competition of misleading advertising or labeling.
In a competitive environment, a company’s communications may also be subject to heightened scrutiny from regulators and competitors under laws, regulations, and guidance about promotional communications (advertising and promotional labeling) and non-promotional communications (e.g., certain educational and scientific exchange), and with regard to potential competitor actions under federal law (such as the Lanham Act) and congruous state law, which protect businesses against the unfair competition of misleading advertising or labeling.
Such regulatory authorities may impose a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
Such regulatory authorities may impose a clinical hold, suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
While we develop charters that guide the nature of the DSMB meetings, their analysis and interpretation of study data occurs independently from us and is wholly within their control.
While we develop charters that guide the nature of the IRB and DSMB meetings, their analysis and interpretation of study data occurs independently from us and is wholly within their control.
We contract with third parties for the manufacture of BRIUMVI for commercial supply, as well as all of our clinical product supply, and we expect to continue to do so.
We contract with third parties for the manufacture and testing of BRIUMVI for commercial supply, as well as all of our clinical product supply, and we expect to continue to do so.
Any delays in our pre-clinical or future clinical development programs may harm our business, financial condition and prospects significantly. We may also incur additional costs if enrollment is increased. In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services.
Any delays in our preclinical or future clinical development programs may harm our business, financial condition and prospects significantly. We may also incur additional costs if enrollment is increased. In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services.
Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete pre-clinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, is difficult to design and implement, can take many years to complete and is uncertain as to outcome.
Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, is difficult to design and implement, can take many years to complete and is uncertain as to outcome.
Key national economies, including the United States, have been affected from time to time by economic downturns or recessions, supply chain constraints, rising inflation, restricted credit, poor liquidity, reduced corporate profitability, debt, equity and foreign exchange market volatility, bankruptcies, rising interest rates, unemployment rates and overall uncertainty with respect to the economy.
Key national economies, including the United States, have been affected from time to time by economic downturns or recessions, supply chain constraints, high inflation, restricted credit, poor liquidity, reduced corporate profitability, debt, equity and foreign exchange market volatility, bankruptcies, high interest rates, high unemployment rates and overall uncertainty with respect to the economy.
Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. ​ 31 Table of Contents Negative or inconclusive results from the clinical trials we conduct, unanticipated adverse medical events, or changes in regulatory policy could cause us to have to delay, repeat or terminate the clinical trials.
Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. ​ 36 Table of Contents Negative or inconclusive results from the clinical trials we conduct, unanticipated adverse medical events, or changes in regulatory policy could cause us to have to delay, repeat or terminate the clinical trials.
Furthermore, switching manufacturers may be difficult because the number of potential manufacturers is limited. It may be difficult or impossible for us to find a replacement manufacturer quickly or on terms acceptable to us, or at all. Some of our product and product candidates are currently manufactured in relatively small batches for use in pre-clinical and clinical studies.
Furthermore, switching manufacturers may be difficult because the number of potential manufacturers is limited. It may be difficult or impossible for us to find a replacement manufacturer quickly or on terms acceptable to us, or at all. Some of our product and product candidates are currently manufactured in relatively small batches for use in preclinical and clinical studies.
BRIUMVI, as well as other drugs that we may bring to the market in the future, may not gain market acceptance by physicians, patients, third-party payors and others in the healthcare community. As a result, we may not generate significant revenues or meet our revenue projections or guidance and may not become profitable.
BRIUMVI, as well as other drugs that we may bring to the market in the future, may not gain market acceptance by physicians, patients, third-party payors and others in the healthcare community. As a result, we may not generate significant revenues or meet our revenue and operating expenses projections or guidance and may not become profitable.
Regulatory approvals for our product or any of our product candidates may be subject to conditions and limitations on the approved indicated uses for which the product may be marketed or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the approved product candidate.
Regulatory approvals for our product or any of our product candidates may be subject to conditions and limitations on the approved indicated uses for which the product may be marketed or contain requirements or commitments for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance and pharmacovigilance to monitor the safety and efficacy of the approved product candidate.
We do not currently own or operate, nor do we have any plans to establish in the future, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture, testing, packaging and labeling of any products that we commercialize and our product candidates for pre-clinical development and clinical testing.
We do not currently own or operate, nor do we have any plans to establish in the future, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture, testing, packaging and labeling of any products that we commercialize and our product candidates for preclinical development and clinical testing.
While an unintentional lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
While an unintentional lapse can in many cases be cured by payment of a late fee or by other methods in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
We are transitioning from a company with a research and development focus and commercialization capabilities in oncology to a company capable of supporting commercial activities in neurology and immunology in the U.S. and outside the U.S. This transition involves a wide variety of risks, and we may not be successful in such transition.
We are transitioning from a company with a research and development focus and commercialization capabilities in oncology to a company capable of supporting commercial activities in the U.S. and outside the U.S. This transition involves a wide variety of risks, and we may not be successful in such transition.
Our drug development programs and the potential commercialization of our drug candidates will require substantial additional cash to fund expenses. For some of our drug candidates, we may decide to collaborate with additional pharmaceutical and biotechnology companies for the development and potential commercialization of those drug candidates. ​ We face significant competition in seeking appropriate collaborators.
Our drug development programs and the potential commercialization of our drug candidates will require substantial additional cash to fund related expenses. Therefore, for some of our drug candidates, we may decide to collaborate with additional pharmaceutical and biotechnology companies for the development and potential commercialization of those drug candidates. ​ We face significant competition in seeking appropriate collaborators.
This could create a situation where we are spending more than required and could impact our on-going operations and entail curtailing other important research and development or commercialization efforts, all of which could have a material adverse effect on the Company.
This could create a situation where we are spending more than required and could impact our ongoing operations and entail curtailing other important research and development or commercialization efforts, all of which could have a material adverse effect on the Company.
We do not know whether any of our ongoing or future clinical trials for our product candidates will be completed on schedule, if at all.​ 30 Table of Contents Whether or not and how quickly we complete clinical trials depends in part upon the rate at which we are able to engage clinical research/trial sites and, thereafter, the rate of enrollment of patients, and the rate at which we collect, clean, lock and analyze the clinical trial database.
We do not know whether any of our ongoing or future clinical trials for our product candidates will be completed on schedule, if at all.​ 35 Table of Contents Whether or not, and if so, how quickly, we complete clinical trials depends in part upon the rate at which we are able to engage clinical research/trial sites and, thereafter, the rate of enrollment of patients, and the rate at which we collect, clean, lock and analyze the clinical trial database.
If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors when needed, we may be unable to successfully implement the tasks necessary to achieve our research, development and commercialization goals. Certain anti-takeover provisions in our governing documents and Delaware law could make a third-party acquisition of us difficult.
If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors when needed, we may be unable to successfully implement the tasks necessary to achieve our research, development and commercialization goals. 65 Table of Contents Certain anti-takeover provisions in our governing documents and Delaware law could make a third-party acquisition of us difficult.
Accordingly, our prospects must be considered in light of the uncertainties, risks, expenses and difficulties frequently encountered by companies in the early stages of commercial operations and the competitive environment in which we operate.​ 26 Table of Contents Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or drug candidates and occupy valuable management time and resources.
Accordingly, our prospects must be considered in light of the uncertainties, risks, expenses and difficulties frequently encountered by companies in the early stages of commercial operations and the competitive environment in which we operate.​ Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or drug candidates and occupy valuable management time and resources.
Specifically, such sanctions have included, among other things, a prohibition on doing business with certain Russian companies, officials, and oligarchs; a commitment by certain countries and the European Union to remove selected Russian banks from the Society for Worldwide Interbank Financial Telecommunications (SWIFT) electronic banking network that connects banks globally; and restrictive measures to prevent the Russian Central Bank from undermining the impact of the sanctions.
Specifically, such sanctions have included, among other things, a prohibition on doing business with certain Russian companies, officials, and oligarchs; a commitment by certain countries and the European Union to remove selected Russian banks from the Society for Worldwide Interbank Financial Telecommunications (SWIFT) electronic banking network that connects banks globally; and restrictive measures to prevent certain Russian financial institutions from undermining the impact of the sanctions.
To date, our operations have been limited primarily to organizing and staffing our company, business planning, raising capital, developing our technology, identifying potential drug candidates, undertaking pre-clinical studies and clinical trials, commercializing UKONIQ (withdrawn from sale) and launching and commercializing BRIUMVI.
To date, our operations have been limited primarily to organizing and staffing our company, business planning, raising capital, developing our technology, identifying potential drug candidates, undertaking preclinical studies and clinical trials, commercializing UKONIQ (withdrawn from sale) and launching and commercializing BRIUMVI.
Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials or creating fraudulent data in our pre-clinical studies or clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation.
Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials or creating fraudulent data in our preclinical studies or clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation.
In addition, if the breadth or strength of protection provided by patents and patent applications for our drug candidates is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future products or product candidates. The issuance of a patent does not foreclose challenges to its inventorship, scope, validity or enforceability.
In addition, if the breadth or strength of protection provided by patents and patent applications for our drug candidates is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future products or product candidates. 59 Table of Contents The issuance of a patent does not foreclose challenges to its inventorship, scope, validity or enforceability.
Such problems, if they were to occur, could negatively impact trial results, and depending on the circumstances and scope of concerns could potentially even prevent a trial from being useful or acceptable for regulatory approval.
Such challenges, if they were to occur, could negatively impact trial results, and depending on the circumstances and scope of concerns could potentially even prevent a trial from being useful or acceptable for regulatory approval.
Consequently, we may not be able to prevent third parties from practicing our inventions in certain countries outside the United States and Europe. 49 Table of Contents Proceedings to enforce our future patent rights, if any, in foreign jurisdictions could result in substantial cost and divert our resources and attention from other aspects of our business.
Consequently, we may not be able to prevent third parties from practicing our inventions in certain countries outside the United States and Europe. Proceedings to enforce our future patent rights, if any, in foreign jurisdictions could result in substantial cost and divert our resources and attention from other aspects of our business.
Therefore, such patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. 47 Table of Contents The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has in recent years been the subject of much litigation.
Therefore, such patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has in recent years been the subject of much litigation.
The degree of market acceptance of BRIUMVI, as well as any future product candidates for which we may receive marketing approval, will depend on a number of factors, including: ● the timing of our receipt of marketing approvals, the terms of such approvals, and the countries in which such approvals are obtained; ● the efficacy, safety and tolerability as demonstrated in clinical trials and as compared to alternative treatments; ● the timing of market introduction of BRIUMVI and any of our product candidates, as well as competitive products; ● the indications for which our products are approved, and other aspects of the approved labeling for such products; ● acceptance by physicians, advanced practitioners, major operators of neurology clinics, and patients of our products as safe, tolerable and effective treatments; ● the potential and perceived advantages or disadvantages of our products compared to alternative treatments; ● our ability to offer our products for sale at competitive prices; ● the availability of adequate reimbursement by third-party payors and government authorities; ● the extent of patient cost-sharing obligations, including copays and deductibles; ● changes in regulatory requirements by government authorities for our products; ● relative convenience and ease of administration; ● the prevalence and severity of side effects and adverse events; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the effectiveness of our sales and marketing efforts , as well as those of any current or future partners ; ● protecting our rights in our intellectual property portfolio; ● our ability to maintain a reliable supply of our products that meets market demand; and ● favorable or unfavorable publicity relating to our products or relating to the Company.
The degree of market acceptance of BRIUMVI, as well as any future product candidates for which we may receive marketing approval, will depend on a number of factors, including: ● the timing of our receipt of marketing approvals, the terms of such approvals, and the countries in which such approvals are obtained; ● the efficacy, safety and tolerability as demonstrated in clinical trials and as compared to alternative treatments; ● the timing of market introduction of BRIUMVI and any of our product candidates, as well as competitive products; ● the indications for which our products are approved, and other aspects of the approved labeling for such products; ● acceptance by physicians, advanced practitioners, major operators of neurology clinics, and patients of our products as safe, tolerable and effective treatments; ● the potential and perceived advantages or disadvantages of our products compared to alternative treatments; ● our ability to offer our products for sale at competitive prices; ● the availability of adequate reimbursement by third-party payors and government authorities; ● the extent of patient cost-sharing obligations, including copays and deductibles; ● changes in regulatory requirements by government authorities for our products; ● relative convenience and ease of administration; ● the prevalence and severity of side effects and adverse events; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the effectiveness of our sales and marketing efforts, as well as those of any current or future partners; ● protecting our rights in our intellectual property portfolio; ● our ability to maintain a reliable supply of our products that meets market demand; and ● favorable or unfavorable publicity relating to our products or relating to the Company. 24 Table of Contents In addition, global health concerns could impact commercialization of BRIUMVI.
If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all.
If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on favorable terms or at all.
Similar post-approval studies are required by other regulatory authorities outside of the U.S., including but not limited to, the EMA in the EU and the MHRA in the United Kingdom (UK).
Similar post-approval studies are required by other regulatory authorities outside of the U.S., including but not limited to, the EMA in the EU and the MHRA in the UK.
Our ability to generate sustained revenue depends on a number of factors, including, but not limited to, our ability to: ● successfully complete clinical trials that meet their clinical endpoints; ● initiate and successfully complete all safety, pharmacokinetic, biodistribution, and non-clinical studies required to obtain U.S. and foreign marketing approval for our product and product candidates; ● obtain approval from the FDA and foreign equivalents to market and sell our product and product candidates, and maintain FDA and EMA approvals of BRIUMVI for RMS; ● establish and maintain commercial manufacturing capabilities with third parties that are satisfactory to the regulatory authorities, cost effective, and that are capable of providing commercial supply of our product and product candidates; ● expand on our commercialization infrastructure to commercialize BRIUMVI, and/or entering into collaborations with third parties; and ● achieve market acceptance of BRIUMVI and any other products for which we may receive regulatory approval in the medical community and with third-party payors.
Our ability to generate sustained revenue depends on a number of factors, including, but not limited to, our ability to: ● successfully complete clinical trials that meet their clinical endpoints; ● initiate and successfully complete all safety, pharmacokinetic, biodistribution, and non-clinical studies required to obtain U.S. and foreign marketing approval for our product and product candidates; ● obtain approval from the FDA and foreign equivalents to market and sell our product and product candidates, and maintain FDA, MHRA and EMA approvals of BRIUMVI for RMS; ● establish and maintain commercial manufacturing capabilities with third parties that are satisfactory to the regulatory authorities, cost effective, and that are capable of providing commercial supply of our product and product candidates; ● expand on our commercialization infrastructure to commercialize BRIUMVI, and/or entering into collaborations with third parties; ● obtain, develop, maintain, protect, and defend our intellectual property portfolio; and ● achieve market acceptance of BRIUMVI and any other products for which we may receive regulatory approval in the medical community and with third-party payors.
Should we fail to adequately secure a license to any newly generated intellectual property, our ability to successfully develop or commercialize our products may be hindered, possibly materially. If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.
Should we fail to adequately secure a license to any newly generated intellectual property, our ability to successfully develop or commercialize our products may be hindered, possibly materially. 63 Table of Contents If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.
An adverse result in any litigation or defense proceedings could put one or more of our pending patents at risk of being invalidated, held unenforceable, or interpreted narrowly. In patent litigation in the United States, defendant counterclaims challenging the validity, enforceability or scope of asserted patents are commonplace.
An adverse result in any litigation or defense proceedings could put one or more of our pending patents at risk of being invalidated, held unenforceable, or interpreted narrowly. 61 Table of Contents In patent litigation in the United States, defendant counterclaims challenging the validity, enforceability or scope of asserted patents are commonplace.
Any failure of a depository institution to return any of our deposits, or any other adverse conditions in the financial or credit markets affecting depository institutions, could impact access to our invested cash or cash equivalents and could adversely impact our operating liquidity and financial performance. 28 Table of Contents Risks Related to Drug Development and Regulatory Approval If we are unable to obtain and maintain regulatory approval for our product and product candidates and ultimately cannot successfully commercialize our product or product candidates, or experience significant delays in doing so, our business will be materially harmed.
Any failure of such depository institution to return any of our deposits upon a liquidation of such institution, or any other adverse conditions in the financial or credit markets affecting depository institutions, could impact access to our invested cash or cash equivalents and could adversely impact our operating liquidity and financial performance. 33 Table of Contents Risks Related to Drug Development and Regulatory Approval If we are unable to maintain or obtain regulatory approval for our product and product candidates and ultimately cannot successfully commercialize our product or product candidates, or experience significant delays in doing so, our business will be materially harmed.
Since inception, we have focused our efforts and financial resources on clinical trials, manufacturing of our product and product candidates and preparing to support a commercial product. To date, we have financed our operations primarily through public offerings of our common stock and debt financing. Since inception, we have incurred significant operating losses.
Since inception, we have focused our efforts and financial resources on clinical trials, manufacturing of our products and product candidates, establishing a commercial infrastructure and preparing to support a commercial product. To date, we have financed our operations primarily through public offerings of our common stock and debt financing. Since inception, we have incurred significant operating losses.
In the event of an acceleration of amounts due under the Amended Loan Agreement, as amended, as a result of an event of default, we may not have enough available cash or be able to raise additional funds through equity or debt financings to repay such indebtedness at the time of such acceleration.
In the event of an acceleration of amounts due under the Financing Agreement, as a result of an event of default, we may not have enough available cash or be able to raise additional funds through equity or debt financings to repay such indebtedness at the time of such acceleration.
If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate revenue from their sales. Risks Relating to Our Intellectual Property Our success depends upon our ability to obtain and protect our intellectual property and proprietary technologies.
If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and we may ultimately not be able to generate revenue from their sales. Risks Related to Our Intellectual Property Our success depends upon our ability to obtain and protect our intellectual property and proprietary technologies.
Other reasons that the FDA or regulatory authorities around the world may delay, limit or deny approval of a product candidate, include: ● we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is tolerable and effective for an indication; ● the FDA may not accept clinical data from trials conducted by individual investigators or in countries where the standard of care or the patient population, is potentially different from that of the United States; ● the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; ● we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; ● the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies and/or clinical trials; ● the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA, NDA or other marketing authorization submission to obtain regulatory approval in the United States or elsewhere; ● the FDA or comparable foreign regulatory authorities may identify issues related to the manufacturing processes or facilities of third-party manufacturers with which we or our collaborators currently contract for clinical supplies and plan to contract for commercial supplies; during the course of review, the FDA or foreign regulatory authorities may raise issues and request or require additional preclinical, clinical, chemistry, manufacturing, and control (CMC), or other data and information, and the development and provision of these data and information may be time consuming.
These issues could cause a delay in the FDA’s review, lead the FDA to deny approval, or lead the Company to withdraw a regulatory application. 38 Table of Contents Other reasons that the FDA or regulatory authorities around the world may delay, limit or deny approval of a product candidate, include: ● we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is tolerable and effective for an indication; ● the FDA may not accept clinical data from trials conducted by individual investigators or in countries where the standard of care or the patient population, is potentially different from that of the United States; ● the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; ● we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; ● the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies and/or clinical trials; ● the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA, NDA or other marketing authorization submission to obtain regulatory approval in the United States or elsewhere; ● the FDA or comparable foreign regulatory authorities may identify issues related to the manufacturing processes or facilities of third-party manufacturers with which we or our collaborators currently contract for clinical supplies and plan to contract for commercial supplies; during the course of review, the FDA or foreign regulatory authorities may raise issues and request or require additional preclinical, clinical, chemistry, manufacturing, and control (CMC), or other data and information, and the development and provision of these data and information may be time consuming.
There are risks involved with establishing our own commercialization capabilities. For example, if we are unable to recruit and retain adequate numbers of effective personnel to support the ongoing commercialization of BRIUMVI, we may not be successful in marketing and selling the product.
There are risks involved with developing and expanding our own commercialization capabilities. For example, if we are unable to recruit and retain adequate numbers of effective personnel to support the ongoing commercialization of BRIUMVI, we may not be successful in marketing and selling the product.
This could happen even for a protocol used to support a trial that is subject to an SPA agreement with the FDA. There is no guarantee that the FDA will not delay, limit or deny approval of our product candidates in the future.
This could happen even for a protocol used to support a trial that is subject to a Special Protocol Assessment (SPA) agreement with the FDA. There is no guarantee that the FDA will not delay, limit or deny approval of our product candidates in the future.
Given the long lead times and cost of establishing additional commercial manufacturing sites we expect that we will rely on single contract manufacturers to produce our commercial products under current Good Manufacturing Practice, or cGMP, regulations for many years.
Given the long lead times and cost of establishing additional commercial manufacturing sites we expect that we will rely on single contract manufacturers to produce our commercial products under current Good Manufacturing Practice, or cGMP, regulations for the next several years.
As a result of this volatility, investors may not be able to sell their common stock at or above the price paid for the shares. We are subject to risks related to corporate social responsibility and reputational matters.
As a result of this volatility, investors may not be able to sell their common stock at or above the price paid for the shares. 69 Table of Contents We are subject to risks related to corporate social responsibility and reputational matters.
In addition, the laws of foreign countries may not protect our patent rights to the same extent as the patent laws of the United States. Furthermore, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally twenty years after it is filed.
In addition, the laws of foreign countries may not protect our patent rights to the same extent as the patent laws of the United States. 57 Table of Contents Furthermore, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally twenty years after it is filed.
We may in the future become party to, or threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our drug candidates and technology, including interference proceedings before the USPTO. 50 Table of Contents Our competitors or other third parties may assert infringement claims against us, alleging that our drugs are covered by their patents.
We may in the future become party to, or threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our drug candidates and technology, including interference proceedings before the USPTO. Our competitors or other third parties may assert infringement claims against us, alleging that our drugs are covered by their patents.
Although we maintain product liability insurance coverage, it may not be adequate to cover all liabilities that we may incur. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
Although we maintain product liability insurance coverage, it may not be adequate to cover all liabilities that we may incur. Insurance coverage is increasingly expensive and difficult to obtain and maintain. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
Many drug candidates fail in the early stages of clinical development for safety and tolerability issues or for insufficient clinical activity, despite promising pre-clinical results.
Many drug candidates fail in the early stages of clinical development for safety and tolerability issues or for insufficient clinical activity, despite promising preclinical results.
Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity.
Any internal or government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity.
ITEM 1A. RISK FACTORS. ​ You should carefully consider the following risk factors and the other information contained elsewhere in this Annual Report before making an investment in our securities. If any of the following risks occur, our business, financial condition or operating results could be materially harmed.
ITEM 1A. RISK FACTORS. ​ You should carefully consider the following risk factors and the other information contained elsewhere in this Annual Report on Form 10-K before making an investment in our securities. If any of the following risks occur, our business, financial condition or operating results could be materially harmed.
Our failure or the failure of our CROs or CMOs to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process and could also subject us to enforcement action.
Our failure or the failure of our CROs or Contract Manufacturing Organizations (CMOs) to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process and could also subject us to enforcement action.
We are not certain that our single-source suppliers will be able to supply sufficient quantities of their products or on the timelines necessary to meet our needs, either because of the nature of our agreements with those suppliers, our limited experience with those suppliers, our relative importance as a customer to those suppliers, international political conflicts that may impact trade or the supply chain within a particular region, public health emergencies such as the COVID-19 pandemic or natural disasters that may cause those suppliers to stop work for a period of time or lead to a sudden increase in demand for selected materials resulting in short-term unavailability of such materials.
We are not certain that our single-source suppliers will be able to supply sufficient quantities of their products or on the timelines necessary to meet our needs, either because of the nature of our agreements with those suppliers, our limited experience with those suppliers, our relative importance as a customer to those suppliers, international political conflicts that may impact trade or the supply chain within a particular region, global health crises or natural disasters that may cause those suppliers to stop work for a period of time or lead to a sudden increase in demand for selected materials resulting in short-term unavailability of such materials.
The Hatch-Waxman Act permit a patent term extension of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond 14 years from the date of product approval by the FDA, and only one patent covering the approved product may be extended.
The Hatch-Waxman Act permits a patent term extension of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond fourteen years from the date of product approval by the FDA, and only one patent covering the approved product may be extended.
Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration, and the proposed collaborator’s evaluation of a number of factors.
Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the proposed collaborator’s resources and expertise, the terms and conditions of the proposed collaboration with a third party, and the proposed collaborator’s evaluation of a number of factors.
To the extent additional debt is added to our current debt levels, the risks described above could increase. We may not have cash available in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due.
To the extent additional debt is added to our current debt levels, the risks described above could increase. 32 Table of Contents We may not have cash available in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due.
If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited. Recruiting and retaining qualified scientific, clinical, manufacturing and medical affairs, and commercial personnel, particularly in MS, will be critical to our success.
If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited. 64 Table of Contents Recruiting and retaining qualified scientific, clinical, manufacturing and medical affairs, and commercial personnel, particularly in MS, will be critical to our success.
In addition to the FDA, the DSMB for our clinical trials may recommend modification to the study design or closure of the study entirely based on the DSMB’s interpretation of the benefit-risk of the study.
In addition to the FDA, the IRB and/or the DSMB for our clinical trials may recommend modification to the study design or closure of the study entirely based on the IRB's and/or DSMB’s interpretation of the benefit-risk of the study.
Orphan Drug Act may be subject to amendments that could reduce the period of marketing exclusivity or change the qualifications for orphan drug designation, which could adversely impact our products or product candidates that have or may be eligible for orphan drug designation. 34 Table of Contents We are conducting clinical trials and anticipate conducting additional clinical trials for our product and product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations or clinical trial activities in such locations may be impacted by political conditions, including international conflict.
Orphan Drug Act may be subject to amendments that could reduce the period of marketing exclusivity or change the qualifications for orphan drug designation, which could adversely impact our products or product candidates that have or may be eligible for orphan drug designation. 40 Table of Contents We are conducting clinical trials and anticipate conducting additional clinical trials for our product and product candidates at sites outside the United States, and trials conducted in such locations or clinical trial activities in such locations may be impacted by political conditions, including international conflict.
We expect that health care reform measures that may be adopted in the future, may result in more rigorous coverage criteria, increased manufactured financial liability and additional downward pressure on the price that we may receive for any of our product candidates, if approved.
We expect that health care reform measures that may be adopted in the future, may result in increased manufactured financial liability and additional downward pressure on the price that we may receive for any of our product candidates, if approved.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeEquity Compensation Plan Information ​ ​ Number of ​ ​ ​ securities ​ ​ ​ remaining ​ ​ ​ available for ​ Number of ​ future issuance ​ securities to be ​ under equity ​ issued upon Weighted-average compensation ​ exercise of exercise price of plans (excluding ​ outstanding outstanding securities reflected Plan Category options options in column 1) Equity compensation plans approved by security holders 4,697,029 $ 6.98 8,751,892 Equity compensation plans not approved by security holders — — — Total 4,697,029 $ 6.98 8,751,892 For information about all of our equity compensation plans see Note 6 to our Consolidated Financial Statements included in this report.
Biggest changeEquity Compensation Plan Information ​ ​ Number of ​ ​ ​ securities ​ ​ ​ remaining ​ ​ ​ available for ​ Number of ​ future issuance ​ securities to be ​ under equity ​ issued upon Weighted-average compensation ​ exercise of exercise price of plans (excluding ​ outstanding outstanding securities reflected Plan Category options options in column 1) Equity compensation plans approved by security holders 4,470,216 $ 6.90 4,238,185 Equity compensation plans not approved by security holders — — — Total 4,470,216 $ 6.90 4,238,185 For information about all of our equity compensation plans see Note 6 to our Consolidated Financial Statements included in this report. 76 Table of Contents Stock Performance Graph The following graph compares the cumulative total stockholder return on our common stock for the period from December 31, 2019 through December 31, 2024, with the cumulative total return over such period on (i) the U.S.
CYBERSECURITY Risk Management and Strategy We have implemented and maintain various information security processes designed to mitigate risks on a case-by-case basis from cybersecurity threats to our critical computer networks, third party-hosted services, communications systems, hardware and software, and our critical data, including intellectual property, confidential information that is proprietary, strategic or competitive in nature, and data related to patients and clinical trials (IT Assets).
CYBERSECURITY Risk Management and Strategy We have implemented and maintain various information security processes designed to mitigate cybersecurity risks, on a case-by-case basis, to our critical computer networks, third party-hosted services, communications systems, hardware and software, and our critical data, including intellectual property, confidential information that is proprietary, strategic or competitive in nature, and data related to patients and clinical trials (IT Assets).
We, and our subsidiaries, are not a party to, and our property is not the subject of, any material pending legal proceedings. ITEM 4. MINE SAFETY DISCLOSURES. None. 57 Table of Contents PART II ITEM 5. MARKET FOR REGISTRANT ’ S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
We, and our subsidiaries, are not a party to, and our property is not the subject of, any material pending legal proceedings. ITEM 4. MINE SAFETY DISCLOSURES. None. 75 Table of Contents PART II ITEM 5. MARKET FOR REGISTRANT ’ S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Depending on the environment, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our IT Assets, including, for example: implementing policies and guidelines governing the individual use and protection of IT Assets by employees, employee training, and leveraging the capability of third-party service providers to support our internal cybersecurity processes.
Depending on the environment, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our IT Assets, which include implementing policies and guidelines governing the individual use and protection of IT Assets by employees, employee training, and leveraging the capability of third -party service providers to support our internal cybersecurity processes.
Risk Factors in this Annual Report on Form 10-K, including the risk factor captioned “Our internal information technology systems, or those of our third-party CROs, CMOs, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug candidates’ development programs and our commercialization of any products for which we receive regulatory approval.” Governance Our information technology (IT) team leads the Company’s overall cybersecurity efforts and is responsible for the day-to-day management of risks we face, while our Board of Directors/management provides guidance on the oversight of risk management.
Risk Factors in this Annual Report on Form 10-K, including the risk factor captioned “Our internal information technology systems, or those of our third-party CROs, CMOs, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug candidates’ development programs and our commercialization of any products for which we receive regulatory approval.” Governance The Board and our Chief Executive Officer is responsible for oversight of the Company’s overall risk management program, including as to cybersecurity related risks, while management is responsible for the day-to-day risk management processes.
The Company’s information security program evaluates threats posed by internal and external factors and supports daily operational functions that prevent unauthorized access or compromise.
The Company’s information security program, which is integrated into our overall risk management processes, evaluates threats posed by internal and external factors and supports daily operational functions that prevent unauthorized access or compromise.
The graph assumes an investment of $100 on December 31, 2018, in our common stock (at the adjusted closing market price) and in each of the indices listed above, and assumes the reinvestment of all dividends. Measurement points are December 31 of each year. * $100 invested on December 31, 2018 in stock or index, including reinvestment of dividends.
Index of The Nasdaq Stock Market and (ii) the Biotechnology Index of The Nasdaq Stock Market. The graph assumes an investment of $100 on December 31, 2019, in our common stock (at the adjusted closing market price) and in each of the indices listed above, and assumes the reinvestment of all dividends.
Market Information Our common stock is listed on the Nasdaq Capital Market and trades under the symbol “TGTX”. Holders The number of record holders of our common stock as of February 23, 2024 was 214.
Market Information Our common stock is listed on the Nasdaq Capital Market and trades under the symbol “TGTX”. Holders The number of record holders of our common stock as of February 25, 2025 was 204. Dividends We have never declared or paid any cash dividends on our common stock.
Securities Authorized for Issuance Under Equity Compensation Plans The following table provides information as of December 31, 2023, regarding the securities authorized for issuance under our equity compensation plans, the TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan (the 2012 Incentive Plan) and the TG Therapeutics, Inc. 2022 Incentive Plan (the 2022 Incentive Plan).
Any future determination to pay dividends will be at the discretion of our board of directors. Securities Authorized for Issuance Under Equity Compensation Plans The following table provides information as of December 31, 2024, regarding the securities authorized for issuance under the TG Therapeutics, Inc. 2022 Incentive Plan (the 2022 Incentive Plan). .
Additionally, the Vice President of IT receives regular reports from the corporate IT Security Team concerning the Company’s significant cybersecurity threats and risks and the processes the Company has implemented to address them. Significant events are reported to the Chief Financial Officer. ITEM 2.
Our Vice President of IT receives regular reports from the corporate IT Security Team, together with information provided by our third-party service organizations that monitor the Company’s IT environment, regarding the Company’s material cybersecurity threats and risks and the processes the Company has implemented to address them, which are reported to the Chief Financial Officer. 74 Table of Contents ITEM 2.
We will continue to monitor proposed cybersecurity disclosure rules from the SEC and alter our procedures accordingly. Risks from cybersecurity threats have, to date, not materially affected us, our business strategy, results of operations or financial condition.
Risks from cybersecurity threats have not materially affected or are currently viewed as not reasonably likely to materially affect us, our business strategy, results of operations or financial condition.
Our Information Security Incident Response Plan is designed to escalate cybersecurity incidents, depending on the circumstances, to appropriate stakeholders as defined by internal Standard Operating Procedures. As part of such process, the corporate IT Security Team receives aggregate monthly reports from a third-party managed services organization contracted to monitor the TGTX IT environment.
We have also implemented a well-established information security incident response plan, which is designed to escalate cybersecurity incidents, depending on the circumstances, to appropriate stakeholders as defined by internal standard operating procedures. We continue to monitor proposed cybersecurity disclosure rules from the SEC and alter our procedures accordingly.
Removed
The potential consequences of a material cybersecurity incident could include reputational damage, litigation with third parties, regulatory criticism or proceedings and increased cybersecurity protection and remediation costs, which in turn could materially adversely affect our results of operations.
Added
These processes are aligned with standard industry frameworks, such as the National Institute of Standards and Technology, Committee of Sponsoring Organizations, International Organization for Standardization 27001, and other industry standards.
Removed
Dividends We have never declared or paid any cash dividends on our common stock and do not anticipate paying any cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of directors.
Added
To further improve the effectiveness of our information security processes, we engage third -party service organizations to monitor the Company’s information technology (IT) environment, conduct evaluations of the effectiveness of our security controls and provide aggregate monthly reports to our corporate IT Security Team regarding the results of such third -party assessments, training and vulnerability testing, data security posture, material cybersecurity risks and areas of improvement.
Removed
There were no additional shares available to be issued under the 2012 Incentive Plan.
Added
However, the scope and impact of any future cybersecurity incidents cannot be predicted and there can be no assurance that our information security program will be effective in preventing material cybersecurity incidents in the future.
Removed
COMMON STOCK PERFORMANCE GRAPH The following graph compares the cumulative total stockholder return on our common stock for the period from December 31, 2018 through December 31, 2023, with the cumulative total return over such period on (i) the U.S. Index of The Nasdaq Stock Market and (ii) the Biotechnology Index of The Nasdaq Stock Market.
Added
The Board receives regular reports from our Chief Executive Officer, Chief Financial Officer and other members of management, regarding material cybersecurity threats and risks, effectiveness of our information security processes and status of ongoing cybersecurity initiatives and strategies.
Added
Our information technology (IT) team, which is overseen by our Vice President of IT, is responsible for the identification, assessment and management of cybersecurity risks we face and ensuring effective implementation of the Company’s overall cybersecurity efforts.
Added
Our Vice President of IT has over 25 years of experience in IT systems, including cybersecurity risk management and incident response, and holds multiple industry-recognized certifications.
Added
Measurement points are December 31 of each year. * $100 invested on December 31, 2019 in stock or index, including reinvestment of dividends. Fiscal Years ending December 31.
Added
Sale of Unregistered Securities Not applicable. 77 Table of Contents Purchases of Equity Securities by the Issuer and Affiliated Purchasers The following table summarizes our common stock repurchase activity during the fourth quarter of 2024: Period (a) (b) (c) (d) Total Number of Shares (or Units) Purchased Average Price Paid per Share (or Unit) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs* October 1, 2024 through October 31, 2024 111,031 $23.12 111,031 $95,284,298 November 1, 2024 through November 30, 2024 19,676 $32.33 19,676 $94,648,121 December 1, 2024 through December 31, 2024 103,586 $32.90 103,586 $91,240,017 Total 234,293 $24.51 234,293 $91,240,017 *Transaction fees are excluded.
Added
In August 2024, the Company announced that its Board of Directors had authorized and approved a share repurchase program for up to $100 million of the currently outstanding shares of the Company’s common stock.
Added
Repurchases under the program may be made using open market purchases, privately negotiated transactions, block purchases or other methods in accordance with applicable federal securities laws, including Rule 10b-18 of the Exchange Act.
Added
The share repurchase program does not have a fixed expiration date, may be suspended or discontinued at any time, and does not obligate us to acquire any particular amount of our common stock.
Added
We repurchased a total of approximately 0.3 million shares of our common stock for approximately $8.8 million under our share repurchase program for the year ended December 31, 2024. Approximately $91.2 million remains available for repurchase of shares under the current authorized program.
Added
Future repurchases of common stock will be dependent upon our financial position, results of operations, outlook, liquidity and other factors we deem relevant.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

216 edited+115 added−85 removed152 unchanged
Biggest changeAlso, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. ​ /s/ KPMG LLP ​ New York, New York February 29, 2024 F-3 Table of Contents TG Therapeutics, Inc. and Subsidiaries Consolidated Balance Sheets as of December 31 (in thousands, except share and per share amounts) ​ December 31, December 31, ​ 2023 2022 ​ ​ ​ Assets Current assets: ​ ​ Cash and cash equivalents $ 92,933 $ 102,304 Short-term investment securities 124,575 59,374 Accounts receivable, net 51,093 — Inventories 39,823 — Prepaid research and development 4,183 4,237 Other current assets 5,336 2,359 Total current assets 317,943 168,274 Restricted cash 1,285 1,273 Long-term investment securities — 12,404 Right of use assets 8,050 8,888 Leasehold interest, net 1,415 1,627 Equipment, net 95 307 Goodwill 799 799 Total assets $ 329,587 $ 193,572 ​ Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses $ 38,471 $ 42,019 Other current liabilities 1,631 1,169 Lease liability – current portion 1,446 1,581 Accrued compensation 12,172 8,432 Total current liabilities 53,720 53,201 Deferred revenue 6,016 305 Loan payable 100,118 71,135 Lease liability – non-current 9,231 10,344 Total liabilities 169,085 134,985 Commitments and contingencies Stockholders’ equity: Common stock, $ 0.001 par value per share ( 175,000,000 shares authorized, 151,465,598 and 146,426,697 shares issued, 151,424,289 and 146,385,388 shares outstanding at December 31, 2023 and December 31, 2022, respectively 151 146 Additional paid-in capital 1,674,946 1,585,708 Treasury stock, at cost, 41,309 shares at December 31, 2023 and December 31, 2022 (234 ) (234 ) Accumulated deficit (1,514,361 ) (1,527,033 ) Total stockholders’ equity 160,502 58,587 Total liabilities and stockholders’ equity $ 329,587 $ 193,572 The accompanying notes are an integral part of the consolidated financial statements. ​ F-4 Table of Contents TG Therapeutics, Inc. and Subsidiaries Consolidated Statements of Operations for the Years Ended December 31 (in thousands, except share and per share amounts) ​ 2023 2022 2021 Revenue: Product revenue, net 92,005 2,633 6,537 License, milestone and other revenue $ 141,657 $ 152 $ 152 Total revenue 233,662 2,785 6,689 ​ Costs and expenses: Cost of revenue 14,131 265 790 Research and development: Noncash compensation 13,010 13,224 24,047 Other research and development 63,182 112,128 198,532 Total research and development 76,192 125,352 222,579 ​ ​ ​ ​ Selling, general and administrative: ​ ​ ​ Noncash compensation 24,923 5,961 37,227 Other selling, general and administrative 97,783 64,046 90,863 Total selling, general and administrative 122,706 70,007 128,090 ​ ​ ​ ​ Total costs and expenses 213,029 195,624 351,459 ​ Operating income (loss) 20,633 (192,839) (344,770) ​ Other expense (income): Interest expense 12,615 10,191 5,638 Other income (5,044) (4,695) (2,307) Total other expense (income), net 7,571 5,496 3,331 ​ Net income (loss) before taxes $ 13,062 $ (198,335) $ (348,101) Income taxes 390 — — Net income (loss) $ 12,672 $ (198,335) $ (348,101) ​ Net income (loss) per common share: Basic $ 0.09 $ (1.46) $ (2.63) Diluted $ 0.09 $ (1.46) $ (2.63) Weighted-average shares outstanding: Basic 141,955,112 135,411,258 132,222,753 Diluted 148,508,465 135,411,258 132,222,753 The accompanying notes are an integral part of the consolidated financial statements.
Biggest changeAlso, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. ​ /s/ KPMG LLP ​ New York, New York March 3, 2025 F-3 Table of Contents TG Therapeutics, Inc. and Subsidiaries Consolidated Balance Sheets as of December 31 (in thousands, except share and per share amounts) ​ December 31, December 31, ​ 2024 2023 ​ ​ ​ Assets Current assets: ​ ​ Cash and cash equivalents $ 179,894 $ 92,933 Short-term investment securities 131,106 124,575 Accounts receivable, net 129,185 51,093 Inventories 110,458 39,823 Other current assets 15,716 9,519 Total current assets 566,359 317,943 Restricted cash 1,298 1,285 Long-term investment securities 808 — Right of use assets 7,151 8,050 Other Noncurrent Assets(1) 2,074 2,309 Total assets $ 577,690 $ 329,587 ​ Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses $ 58,296 $ 38,471 Other current liabilities(1) 4,627 1,479 Lease liability – current portion 1,157 1,446 Deferred revenue - current portion(1) 11,414 152 Accrued compensation 15,185 12,172 Total current liabilities 90,679 53,720 Deferred revenue, non-current portion 12,085 6,016 Loan payable 244,429 100,118 Lease liability – non-current 8,133 9,231 Total liabilities 355,326 169,085 Commitments and contingencies Stockholders’ equity: Common stock, $ 0.001 par value per share ( 190,000,000 and 175,000,000 shares authorized, 156,204,159 and 151,465,598 shares issued, 155,836,256 and 151,424,289 shares outstanding at December 31, 2024 and December 31, 2023, respectively 156 151 Additional paid-in capital 1,760,396 1,713,162 Treasury stock, at cost, 367,903 and 41,309 shares at December 31, 2024 and December 31, 2023 (8,994 ) (234 ) Accumulated deficit (1,529,194 ) (1,552,577 ) Total stockholders’ equity 222,364 160,502 Total liabilities and stockholders’ equity $ 577,690 $ 329,587 The accompanying notes are an integral part of the consolidated financial statements.
Other selling, general and administrative expenses increased for the year ended December 31, 2023, by approximately $33.9 million to $97.8 million as compared to the prior year ended December 31, 2022.
Other Selling, General and Administrative. Other selling, general and administrative expenses increased for the year ended December 31, 2023, by approximately $33.9 million to $97.8 million as compared to the prior year ended December 31, 2022.
We may be dependent upon significant future financing to provide the cash necessary to execute our ongoing and future operations, including the commercialization of any of our drug candidates.
We may be dependent upon significant future financing to provide the cash necessary to execute our ongoing and future operations, including the commercialization of any of our drug candidates.
To achieve this core principle, Topic 606 includes provisions within a five -step model that includes i) identifying the contract with a customer, ii) identifying the performance obligations in the contract, iii) determining the transaction price, iv) allocating the transaction price to the performance obligations, and v) recognizing revenue when, or as, an entity satisfies a performance obligation.
To achieve this core principle, Topic 606 includes provisions within a five -step model that includes i) identifying the contract with a customer, ii) identifying the performance obligations in the contract, iii) determining the transaction price, iv) allocating the transaction price to the performance obligations, and v) recognizing revenue when, or as, an entity satisfies a performance obligation.
At contract inception, we assess the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are performance obligations. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied.
At contract inception, we assess the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are performance obligations. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied.
The amount of variable consideration that is included in the transaction price may be subject to constraint and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.
The amount of variable consideration that is included in the transaction price may be subject to constraint and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.
Actual amounts of consideration received may ultimately differ from the Company's estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment.
Actual amounts of consideration received may ultimately differ from the Company's estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment.
During the year ended December 31, 2023, we sold a total of 1,385,700 shares of common stock under the 2022 ATM for aggregate total gross proceeds of approximately $47.1 million at an average selling price of $34.01 per share, resulting in net proceeds of approximately $46.3 million after deducting commissions and other transactions costs.
During the year ended December 31, 2023, we sold a total of 1,385,700 shares of common stock under the 2022 ATM for aggregate total gross proceeds of approximately $47.1 million at an average selling price of $34.01 per share, resulting in net proceeds of approximately $46.3 million after deducting commissions and other transactions costs.
The First Amendment amended the terms of the Amended Loan Agreement to, among other things: (i) issue an advance of $25.0 million drawn at the First Amendment Effective Date (the Tranche 3A Advance), (ii) provide for the formal expiration of Tranche 2, (iii) change the draw amounts and dates available under subsequent tranches, including splitting the remaining balance of Tranche 3 into two additional advances in an aggregate principal amount of up to $20.0 million, in increments of $10.0 million (a Tranche 3B Advance and a Tranche 3C Advance), decreasing the amount available under Tranche 4 from $65.0 million to $60.0 million, and adding a Tranche 5 of $25.0 million, subject to the achievement of revenue related performance milestones, (iv) extend the interest only period from February 1, 2025 to August 1, 2025 and (v) modify the cash interest rate to be the greater of either (a) the “prime rate” as reported in The Wall Street Journal plus 1.20%, and (b) 8.95%.
The First Amendment amended the terms of the Amended Loan Agreement to, among other things: (i) issue an advance of $25.0 million drawn at the First Amendment Effective Date (the Tranche 3A Advance), (ii) provide for the formal expiration of Tranche 2, (iii) change the draw amounts and dates available under subsequent tranches, including splitting the remaining balance of Tranche 3 into two additional advances in an aggregate principal amount of up to $20.0 million, in increments of $10.0 million (a Tranche 3B Advance and a Tranche 3C Advance), decreasing the amount available under Tranche 4 from $65.0 million to $60.0 million, and adding a Tranche 5 of $25.0 million, subject to the achievement of revenue related performance milestones, (iv) extend the interest only period from February 1, 2025 to August 1, 2025 and (v) modify the cash interest rate to be the greater of either (a) the “prime rate” as reported in The Wall Street Journal plus 1.20%, and (b) 8.95%.
Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively.
Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in adults, as well as approval by the European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom (UK), respectively.
You should read the following discussion and analysis in conjunction with “Item 8. Financial Statements and Supplementary Data,” and our consolidated financial statements beginning on page F-1 of this report. Overview TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases.
You should read the following discussion and analysis in conjunction with “Item 8. Financial Statements and Supplementary Data,” and our consolidated financial statements beginning on page F-1 of this report. Overview TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell mediated diseases.
(incorporated by reference to Exhibit 10.8 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.37 Commercialization Agreement by and between TG Therapeutics, Inc. and Neuraxpharm Pharmaceuticals, S.L., dated as of July 28, 2023 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2023). * 10.38 License Agreement, dated January 7, 2024, by and between TG Therapeutics, Inc., TG Cell Therapy, Inc., and Precision BioSciences, Inc. # * 19.1 TG Therapeutics, Inc.
(incorporated by reference to Exhibit 10.8 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). * 10.37 Commercialization Agreement by and between TG Therapeutics, Inc. and Neuraxpharm Pharmaceuticals, S.L., dated as of July 28, 2023 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2023). * 10.38 License Agreement, dated January 7, 2024, by and between TG Therapeutics, Inc., TG Cell Therapy, Inc., and Precision BioSciences, Inc.
Product revenue, net increased for the year ended December 31, 2023 compared to the comparable period ended December 31, 2022 primarily due to an increase in net product revenues from sales of our sole commercial product, BRIUMVI, which was commercially launched in the U.S. in January 2023, following FDA approval.
Total revenue for the year ended December 31, 2023 increased compared to the comparable period ended December 31, 2022 primarily due to an increase in net product revenues from sales of our sole commercial product, BRIUMVI, which was commercially launched in the U.S. in January 2023, following FDA approval.
The Company granted Neuraxpharm the exclusive right to commercialize BRIUMVI in certain territories outside the United States, Canada, and Mexico, the commercialization rights for which had been previously retained by the Company, thus excluding certain Asian countries subject to previously existing partnerships (the Territory).
The Company granted Neuraxpharm the exclusive right to commercialize BRIUMVI in certain territories outside the United States, Canada, and Mexico, the commercialization rights for which had been previously retained by the Company, and excluding certain Asian countries subject to previously existing partnerships (the Territory).
Our ability to achieve profitability depends on our ability to generate revenue and many other factors, including our ability to successfully commercialize our drug candidates alone or in partnership; successfully complete any post-approval regulatory obligations and our ability to maintain or obtain regulatory approval for our drug candidates.
Our ability to achieve continued profitability depends on our ability to generate revenue and many other factors, including our ability to successfully commercialize our drug candidates alone or in partnership; successfully complete any post-approval regulatory obligations and our ability to maintain or obtain regulatory approval for our drug candidates.
Our ability to achieve profitability depends on our ability to generate revenue and many other factors, including our ability to successfully commercialize our drug candidates alone or in partnership; successfully complete any post-approval regulatory obligations; and our ability to maintain or obtain regulatory approval for our drug candidates.
Our ability to achieve continued profitability depends on our ability to generate revenue and many other factors, including our ability to successfully commercialize our drug candidates alone or in partnership; successfully complete any post-approval regulatory obligations; and our ability to maintain or obtain regulatory approval for our drug candidates.
Variable consideration includes the following components, which are described below: chargebacks, government rebates, trade discounts and allowances, product returns, and co-payment assistance. 65 Table of Contents These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against the Company's customer account) or a liability (if the amount is expected to be settled with a cash payment).
Variable consideration includes the following components, which are described below: chargebacks, government rebates, trade discounts and allowances, product returns, and co-payment assistance. 87 Table of Contents These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against the Company's customer account) or a liability (if the amount is expected to be settled with a cash payment).
Weiss (incorporated by reference to Exhibit 10.18 to the Registrant’s Form 10-K/A for the year ended December 31, 2016). † ​ ​ 10.16 License Agreement between TG Therapeutics, Inc. and Jiangsu Hengrui Medicine Co., dated January 8, 2018 (incorporated by reference to Exhibit 10.20 to the Registrant’s Form 10-K for the year ended December 31, 2017). * ​ ​ 10.17 Joint Venture and License Option Agreement by and between TG Therapeutics, Inc. and Novimmune S.A., dated June 18, 2018 (incorporated by reference to Exhibit 10.20 to the Registrant’s Form 10-Q for the quarter ended June 30, 2018). * 70 Table of Contents 10.18 Master Services Agreement between Samsung Biologics Co., Ltd.
Weiss (incorporated by reference to Exhibit 10.18 to the Registrant’s Form 10-K/A for the year ended December 31, 2016). † ​ ​ 10.16 License Agreement by and between TG Therapeutics, Inc. and Jiangsu Hengrui Medicine Co., dated January 8, 2018 (incorporated by reference to Exhibit 10.20 to the Registrant’s Form 10-K for the year ended December 31, 2017). * ​ ​ 10.17 Joint Venture and License Option Agreement by and between TG Therapeutics, Inc. and Novimmune S.A., dated June 18, 2018 (incorporated by reference to Exhibit 10.20 to the Registrant’s Form 10-Q for the quarter ended June 30, 2018). * 94 Table of Contents 10.18 Master Services Agreement by and between Samsung Biologics Co., Ltd.
All of the unrecognized tax benefits, if recognized, would be offset by the valuation allowance. ​ F- 25 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements NOTE 10 – LICENSE AGREEMENTS BRIUMVI (Ublituximab) In January 2012, we entered into an exclusive license agreement with LFB Biotechnologies, GTC Biotherapeutics and LFB/GTC LLC, all wholly-owned subsidiaries of LFB Group, relating to the development of ublituximab (the LFB License Agreement).
All of the unrecognized tax benefits, if recognized, would be offset by the valuation allowance. ​ F- 30 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements NOTE 10 – LICENSE AGREEMENTS BRIUMVI (Ublituximab) In January 2012, we entered into an exclusive license agreement with LFB Biotechnologies, GTC Biotherapeutics and LFB/GTC LLC, all wholly-owned subsidiaries of LFB Group, relating to the development of ublituximab (the LFB License Agreement).
The License to the Company’s intellectual property represents a distinct performance obligation, therefore, the $140 million non-refundable upfront payment related to this performance obligation was recognized as License Revenue in 2023.
The License to the Company’s intellectual property represents a distinct performance obligation, therefore, the $140.0 million non-refundable upfront payment related to this performance obligation was recognized as License Revenue in 2023.
As of December 31, 2023 , we determined an allowance for expected credit losses related to outstanding accounts receivable was currently not required based upon our review of contractual payment terms and individual customer circumstances. COST OF REVENUE Cost of revenue consists primarily of third -party manufacturing costs, distribution, overhead and royalties owed to our licensing partner for BRIUMVI sales.
As of December 31, 2024 , we determined an allowance for expected credit losses related to outstanding accounts receivable was currently not required based upon our review of contractual payment terms and individual customer circumstances. COST OF REVENUE Cost of revenue consists primarily of third -party manufacturing costs, distribution, overhead and royalties owed to our licensing partner for BRIUMVI sales.
We anticipate that our cash, cash equivalents, and investment securities as of December 31, 2023, combined with projected revenues associated with the sale of BRIUMVI in the U.S. and ex-U.S., will provide sufficient liquidity for more than a twelve-month period from the date of filing this Annual Report on Form 10-K.
We anticipate that our cash, cash equivalents, and investment securities as of December 31, 2024, combined with projected revenues associated with the sale of BRIUMVI in the U.S. and ex-U.S., will provide sufficient liquidity for more than a twelve-month period from the date of filing this Annual Report on Form 10-K.
We anticipate that our cash, cash equivalents, and investment securities as of December 31, 2023, combined with projected revenues associated with the sale of BRIUMVI in the U.S. and ex-U.S., will provide sufficient liquidity for more than a twelve -month period from the date of filing this Annual Report on Form 10 -K.
We anticipate that our cash, cash equivalents, and investment securities as of December 31, 2024, combined with projected revenues associated with the sale of BRIUMVI in the U.S. and ex-U.S., will provide sufficient liquidity for more than a twelve -month period from the date of filing this Annual Report on Form 10 -K.
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.
However, NOLs and tax credits generated from those prior years could still be adjusted upon audit. ​ The Company would recognize interest and penalties, if any, to uncertain tax position in income tax expense in the statement of operations. There was no accrual for interest and penalties related to uncertain tax positions for 2023 .
However, NOLs and tax credits generated from those prior years could still be adjusted upon audit. ​ The Company would recognize interest and penalties, if any, to uncertain tax position in income tax expense in the statement of operations. There was no accrual for interest and penalties related to uncertain tax positions for 2024.
In making this assessment, our management used the criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO Framework. Our management has concluded that, as of December 31, 2023, our internal control over financial reporting was effective based on these criteria.
In making this assessment, our management used the criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO Framework. Our management has concluded that, as of December 31, 2024, our internal control over financial reporting was effective based on these criteria.
As of December 31, 2023, management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (Exchange Act)).
As of December 31, 2024, management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (Exchange Act)).
F- 12 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements NET INCOME (LOSS) PER COMMON SHARE Basic net income (loss) per share of our common stock is calculated by dividing net income (loss) applicable to the common stock by the weighted-average number of our common stock outstanding for the period.
F- 13 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements NET INCOME (LOSS) PER COMMON SHARE Basic net income (loss) per share of our common stock is calculated by dividing net income (loss) applicable to the common stock by the weighted-average number of our common stock outstanding for the period.
Power (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on January 7, 2015). † ​ ​ 10.9 License Agreement dated January 30, 2012, by and among the Registrant, GTC Biotherapeutics, Inc., LFB Biotechnologies S.A.S. and LFB/GTC LLC (incorporated by reference to Exhibit 10.35 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). * ​ ​ 10.10 Sublicense Agreement between TG Therapeutics, Inc. and Ildong Pharmaceutical Co.
Power (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on January 7, 2015). † ​ ​ 10.9 License Agreement dated January 30, 2012, by and among TG Therapeutics, Inc., GTC Biotherapeutics, Inc., LFB Biotechnologies S.A.S. and LFB/GTC LLC (incorporated by reference to Exhibit 10.35 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). * ​ ​ 10.10 Sublicense Agreement, dated November 13, 2012, by and between TG Therapeutics, Inc. and Ildong Pharmaceutical Co.
Consolidated Financial Statements ​ Page Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID: 185) F-1 ​ ​ Consolidated Balance Sheets as of December 31, 2023 and 2022 F-4 ​ ​ Consolidated Statements of Operations for the years ended December 31, 2023, 2022 and 2021 F-5 ​ ​ Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2023, 2022 and 2021 F-6 ​ ​ Consolidated Statements of Cash Flows for the years ended December 31, 2023, 2022 and 2021 F-7 ​ ​ Notes to Consolidated Financial Statements F-8 ​ 72 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and Board of Directors TG Therapeutics, Inc.: Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated balance sheets of TG Therapeutics, Inc. and subsidiaries (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2023, and the related notes (collectively, the consolidated financial statements).
Consolidated Financial Statements ​ Page Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID: 185) F-1 ​ ​ Consolidated Balance Sheets as of December 31, 2024 and 2023 F-4 ​ ​ Consolidated Statements of Operations for the years ended December 31, 2024, 2023 and 2022 F-5 ​ ​ Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2024, 2023 and 2022 F-6 ​ ​ Consolidated Statements of Cash Flows for the years ended December 31, 2024, 2023 and 2022 F-7 ​ ​ Notes to Consolidated Financial Statements F-8 ​ 96 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and Board of Directors TG Therapeutics, Inc.: Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated balance sheets of TG Therapeutics, Inc. and subsidiaries (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2024, and the related notes (collectively, the consolidated financial statements).
Under the terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab. For the period ended December 31, 2023 , we have incurred expenses of approximately $31.0 million related to the achievement of certain milestones of the LFB License Agreement.
Under the terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab. For the period ended December 31, 2024 , we have incurred expenses of approximately $31.0 million related to the achievement of certain milestones of the LFB License Agreement.
We expect the cost of revenue for BRIUMVI to increase in relation to product revenues as we deplete these inventories and we expect to use the remaining pre-commercialization inventory for product sales through the first half of 2025 Noncash Compensation Expense (Research and Development).
We expect the cost of revenue for BRIUMVI to increase in relation to product revenues as we deplete these inventories and we expect to use the remaining pre-commercialization inventory for product sales through the first quarter of 2025. Noncash Compensation Expense (Research and Development).
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) or Rule 15d-15(f) under the Exchange Act). Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) or Rule 15d-15(f) under the Exchange Act). Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2024.
Examples of estimated accrued research and development expenses include: ​ ● fees paid to contract research organizations (CROs) in connection with clinical studies; ● fees paid to contract manufacturing organizations (CMOs); ● fees paid to trial sites in connection with clinical studies; and ● fees paid to vendors associated with licenses/milestones. ​ We base our expenses related to clinical studies on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical studies on our behalf.
Examples of estimated accrued research and development expenses include: ​ ● fees paid to contract research organizations (CROs) in connection with clinical studies; ● fees paid to contract manufacturing organizations (CMOs); ● fees paid to trial sites in connection with clinical studies; and ● fees paid to vendors associated with licenses/milestones. ​ 88 Table of Contents We base our expenses related to clinical studies on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical studies on our behalf.
These expenses are included in other research and development expenses in the accompanying consolidated statements of operations. As of December 31, 2023 , we had approximately zero recorded in accounts payable related to the LFB License Agreement.
These expenses are included in other research and development expenses in the accompanying consolidated statements of operations. As of December 31, 2024 , we had approximately zero recorded in accounts payable related to the LFB License Agreement.
The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our commercialization efforts for BRIUMVI, preparations for the potential commercialization of our other drug candidates, and the timing, design and conduct of clinical trials for our drug candidates as well as the costs associated with licensing or otherwise acquiring new product candidates.
The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our commercialization efforts for BRIUMVI, and the timing, design and conduct of clinical trials for our drug candidates as well as the costs associated with licensing or otherwise acquiring new product candidates.
The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our commercialization efforts for BRIUMVI, preparations for the potential commercialization of our other drug candidates, and the timing, design and conduct of clinical trials for our drug candidates as well as the costs associated with licensing or otherwise acquiring new product candidates.
The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our commercialization efforts for BRIUMVI and the timing, design and conduct of clinical trials for our drug candidates as well as the costs associated with licensing or otherwise acquiring new product candidates.
As of December 31, 2023 and 2022 , we have approximately $1.3 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement (see Note 7 ). INVESTMENT SECURITIES Investment securities at December 31, 2023 and 2022 consist of short-term and long-term government securities. We classify these securities as held-to-maturity.
As of December 31, 2024 and 2023 , we have approximately $1.3 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement (see Note 7 ). INVESTMENT SECURITIES Investment securities at December 31, 2024 and 2023 consist of short-term government securities. We classify these securities as held-to-maturity.
Pursuant to the Precision License Agreement, the Company will make an upfront payment to Precision of $7.5 million, consisting of (i) $5.25 million in cash and (ii) $2.25 million, as an equity investment, for the purchase of 2,920,816 shares of Precision’s common stock at a price of $0.77 per share.
Pursuant to the Precision License Agreement, the Company made an upfront payment to Precision of $7.5 million, consisting of (i) $5.25 million in cash and (ii) $2.25 million (the Upfront Precision Stock Payment), as an equity investment, for the purchase of 2,920,816 shares of Precision’s common stock at a price of $0.77 per share.
Our consolidated financial statements and the notes thereto, included in Part IV, Item 14(a), part 1, are incorporated by reference into this Item 8. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES. Not applicable. ITEM 9A. CONTROLS AND PROCEDURES. Evaluation of Disclosure Controls and Procedures.
Our consolidated financial statements and the notes thereto, included in Part IV, Item 14(a), part 1, are incorporated by reference into this Item 8. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES. Not applicable. 89 Table of Contents ITEM 9A. CONTROLS AND PROCEDURES. Evaluation of Disclosure Controls and Procedures.
F- 23 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements NOTE 9 – INCOME TAXES We account for income taxes under the asset and liability method.
F- 28 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements NOTE 9 – INCOME TAXES We account for income taxes under the asset and liability method.
The Tax Cuts and Jobs Act of 2017 (TCJA) included changes to the treatment of research and development expenses under IRC Section 174. Formerly, a company could deduct research and development expenses under IRC Section 174 as incurred.
The Tax Cuts and Jobs Act of 2017 (“TCJA”) included changes to the treatment of research and development expenses under IRC Section 174. Formerly, a company could deduct research and development expenses under IRC Section 174 as incurred.
Effective for tax years beginning after December 31, 2021, research and development expenses under IRC Section 174 are required to be capitalized, with an amortization period of 5 years for costs incurred in the U.S. and 15 years for costs incurred in a non-U.S. jurisdiction.
Effective for tax years beginning after December 31, 2021, research and development expenses under IRC Section 174 are required to be capitalized, with an amortization period of 5 years for costs incurred in the US and 15 years for costs incurred in a non-US jurisdiction.
Contents ​ Page Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID: 185) ​ F-1 ​ ​ ​ Consolidated Balance Sheets as of December 31, 2023 and 2022 ​ F-5 ​ ​ ​ Consolidated Statements of Operations for the years ended December 31, 2023, 2022 and 2021 ​ F-6 ​ ​ ​ Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2023, 2022 and 2021 ​ F-7 ​ ​ ​ Consolidated Statements of Cash Flows for the years ended December 31, 2023, 2022 and 2021 ​ F-8 ​ ​ ​ Notes to Consolidated Financial Statements ​ F-9 2.
Contents ​ Page Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID: 185) ​ F-1 ​ ​ ​ Consolidated Balance Sheets as of December 31, 2024 and 2023 ​ F-4 ​ ​ ​ Consolidated Statements of Operations for the years ended December 31, 2024, 2023 and 2022 ​ F-5 ​ ​ ​ Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2024, 2023 and 2022 ​ F-6 ​ ​ ​ Consolidated Statements of Cash Flows for the years ended December 31, 2024, 2023 and 2022 ​ F-7 ​ ​ ​ Notes to Consolidated Financial Statements ​ F-8 2.
With certain exceptions, the Company is no longer subject to U.S. federal and state income tax examinations by tax authorities for years prior to 2020.
With certain exceptions, the Company is no longer subject to U.S. Federal and state income tax examinations by tax authorities for years prior to 2021.
Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. ITEM 9B. OTHER INFORMATION.
Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. 90 Table of Contents ITEM 9B. OTHER INFORMATION.
ITEM 6. REMOVED AND RESERVED 58 Table of Contents ITEM 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future.
ITEM 6. RESERVED 78 Table of Contents ITEM 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future.
Subject to certain limitations, the Company’s return policy allows for eligible returns of commercial products sold for credit under the following circumstances: ● receipt of damaged product; ● shipment errors that were a result of an error by the Company; ● expired product that is returned during the period beginning three months prior to the product’s expiration and ending six months after the expiration date; ● product subject to a recall; and ● product that the Company, at its sole discretion, has specified can be returned for credit. ​ F- 10 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements As of December 31, 2023 , the Company has not received any returns related to sales of BRIUMVI. ​ Co-Payment Assistance Programs: Co-payment assistance is provided to qualified patients with commercial insurance, whereby the Company may provide financial assistance to patients with prescription drug co-payments required by the patient's insurance provider.
Subject to certain limitations, the Company’s return policy allows for eligible returns of commercial products sold for credit under the following circumstances: ● receipt of damaged product; ● shipment errors that were a result of an error by the Company; ● expired product that is returned during the period beginning three months prior to the product’s expiration and ending six months after the expiration date; ● product subject to a recall; and ● product that the Company, at its sole discretion, has specified can be returned for credit. ​ F- 10 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements As of December 31, 2024 , the Company has $0.1 million in returns related to sales of BRIUMVI. ​ Co-Payment Assistance Programs: Co-payment assistance is provided to qualified patients with commercial insurance, whereby the Company may provide financial assistance to patients with prescription drug co-payments required by the patient's insurance provider.
Ltd., dated November 13, 2012 (incorporated by reference to Exhibit 10.37 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2012). * ​ ​ 10.11 License Agreement between TG Therapeutics, Inc. and Ligand Pharmaceuticals Incorporated, dated June 23, 2014 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2014).* ​ ​ 10.12 License Agreement between TG Therapeutics, Inc. and Rhizen Pharmaceuticals SA, dated September 22, 2014 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 20, 2015). * ​ ​ 10.13 Collaboration Agreement between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated March 3, 2015 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended March 31, 2015). * ​ ​ 10.14 Sublicense Agreement between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated May 27, 2016, (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2016). * ​ ​ 10.15 Amendment to Employment Agreement, effective January 1, 2017, between TG Therapeutics, Inc. and Michael S.
(incorporated by reference to Exhibit 10.37 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2012). * ​ ​ 10.11 License Agreement by and between TG Therapeutics, Inc. and Ligand Pharmaceuticals Incorporated, dated June 23, 2014 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2014).* ​ ​ 10.12 License Agreement by and between TG Therapeutics, Inc. and Rhizen Pharmaceuticals SA, dated September 22, 2014 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 20, 2015). * ​ ​ 10.14 Sublicense Agreement by and between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated May 27, 2016, (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2016). * ​ ​ 10.15 Amendment to Employment Agreement, effective January 1, 2017, by and between TG Therapeutics, Inc. and Michael S.
Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, a portion of the manufacturing costs of BRIUMVI units recognized as revenue during the year ended December 31, 2023 were expensed prior to receipt of FDA approval on December 28, 2022, and therefore are not included in costs of product revenue during the current period.​ Our other research and development expenses consist primarily of expenses relating to the design, development, manufacture, testing and enhancement of our drug candidates and technologies, milestone expenses related to in-licensing of new product candidates, fees paid to consultants and outside service providers for clinical and laboratory development, personnel expenses and other facilities-related expenses.
Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, a portion of the manufacturing costs of BRIUMVI units recognized as revenue during the years ended December 31, 2023 and 2024 were expensed prior to receipt of FDA approval on December 28, 2022, and therefore are not included in costs of product revenue during those periods.​ Our other research and development expenses consist primarily of expenses relating to the design, development, manufacture, testing and enhancement of our drug candidates and technologies, milestone expenses related to in-licensing of new product candidates, fees paid to consultants and outside service providers for clinical and laboratory development, personnel expenses and other facilities-related expenses.
During 2023 the Company recognized Other Revenue of $1.5 million related to the Development and Regulatory Activities. The arrangement also provides Neuraxpharm with the right to make optional purchases of BRIUMVI (the “Supply of Licensed Product”). These optional purchases are accounted for as a separate contract when the right to purchase BRIUMVI is exercised.
During 2024 the Company recognized Other Revenue of $1.8 million related to the Development and Regulatory Activities. The arrangement also provides Neuraxpharm with the right to make optional purchases of BRIUMVI (the “Supply of Licensed Product”). These optional purchases are accounted for as a separate contract when the right to purchase BRIUMVI is exercised.
We took possession of this space in February 2022, with rental payments beginning in April 2022. Operating lease cost was $2.2 million, $2.7 million and $2.2 million for the years ended December 31, 2023, 2022 and 2021, respectively.
We took possession of this space in February 2022, with rental payments beginning in April 2022. Operating lease cost was $2.3 million, $2.2 million and $2.7 million for the years ended December 31, 2024, 2023 and 2022, respectively.
Weiss ​ ​ Chairman and Chief Executive Officer 83 Table of Contents POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints each of Michael S. Weiss and Sean A.
Weiss ​ ​ Michael S. Weiss ​ ​ Chairman and Chief Executive Officer F-33 Table of Contents POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints each of Michael S. Weiss and Sean A.
We recorded license revenue of approximately $0.2 million for each of the years ended December 31, 2023, 2022 and 2021 , and at December 31, 2023 and 2022 , have deferred revenue of approximately $0.3 million and $0.5 million, respectively, associated with this $2 million payment.
We recorded license revenue of approximately $0.2 million for each of the years ended December 31, 2024, 2023 and 2022 , and at December 31, 2024 and 2023 , have deferred revenue of approximately $0.2 million and $0.3 million, respectively, associated with this $2 million payment.
The consideration received from Neuraxpharm for the supply of BRIUMVI is recognized by the Company as a component of product revenue, net. As of December 31, 2023, the Company has an unconditional right to receive $1.9 million in consideration from Neuraxpharm related to the performance obligation to supply BRIUMVI, which is recorded as accounts receivable, net.
The consideration received from Neuraxpharm for the supply of BRIUMVI is recognized by the Company as a component of product revenue, net. As of December 31, 2024, the Company has an unconditional right to receive $1.5 million in consideration from Neuraxpharm related to the performance obligation to supply BRIUMVI, which is recorded as accounts receivable, net.
New York, New York February 29, 2024 F-2 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and Board of Directors TG Therapeutics, Inc.: ​ Opinion on Internal Control Over Financial Reporting ​ We have audited TG Therapeutics, Inc. and subsidiaries' (the Company) internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
New York, New York March 3, 2025 F-2 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and Board of Directors TG Therapeutics, Inc.: ​ Opinion on Internal Control Over Financial Reporting ​ We have audited TG Therapeutics, Inc. and subsidiaries' (the Company) internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated February 29, 2024 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated March 3, 2025 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
As of December 31, 2023 , there was approximately $4.1 million of total unrecognized compensation cost related to unvested time-based stock options, which is expected to be recognized over a weighted-average period of 2.6 years. As of December 31, 2023 , the stock options outstanding include options granted to both employees and non-employees which are both time-based and milestone-based.
As of December 31, 2024, there was approximately $1.6 million of total unrecognized compensation cost related to unvested time-based stock options, which is expected to be recognized over a weighted-average period of 1.58 years. As of December 31, 2024, the stock options outstanding include options granted to both employees and non-employees which are both time-based and milestone-based.
Clawback Policy # 101 The following financial information from TG Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2023, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Stockholders’ Equity, (iv) Consolidated Statements of Cash Flows, (v) the Notes to Consolidated Financial Statements. ​ ​ 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). # Filed Herewith. † Indicates management contract or compensatory plan or arrangement. * Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K. ​ ​ TG Therapeutics, Inc.
Clawback Policy (incorporated by reference to Exhibit 97.1 to the Registrant’s Form 10-K for the year ended December 31, 2023). 101 The following financial information from TG Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2024, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Stockholders’ Equity, (iv) Consolidated Statements of Cash Flows, (v) the Notes to Consolidated Financial Statements. ​ ​ 104 Cover Page Interactive Data File (embedded within inline XBRL included as Exhibit 101). # Filed Herewith. † Indicates management contract or compensatory plan or arrangement. * Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K. ​ ​ TG Therapeutics, Inc.
(incorporated by reference to Exhibit 4.5 of the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020). ​ 69 Table of Contents 10.1 Employment Agreement, effective December 29, 2011, between the Registrant and Michael Weiss (incorporated by reference to Exhibit 10.30 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). † ​ ​ 10.2 Restricted Stock Subscription Agreement, effective December 29, 2011, between the Registrant and Michael Weiss (incorporated by reference to Exhibit 10.31 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). † ​ ​ 10.3 Amendment to Restricted Stock Agreement, dated July 12, 2013, by and between TG Therapeutics, Inc. and Michael S.
(incorporated by reference to Exhibit 4.5 of the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020). ​ 93 Table of Contents 10.2 Restricted Stock Subscription Agreement, effective December 29, 2011, by and between TG Therapeutics, Inc. and Michael Weiss (incorporated by reference to Exhibit 10.31 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). † ​ ​ 10.3 Amendment to Restricted Stock Agreement, dated July 12, 2013, by and between TG Therapeutics, Inc. and Michael S.
Research and development expenses consist primarily of costs incurred to third -party service providers for the conduct of research, preclinical and clinical studies, contract manufacturing costs, license milestone fees, personnel costs for our research and development employees, consulting, and other related expenses.
RESEARCH AND DEVELOPMENT COSTS Generally, research and development costs are expensed as incurred. Research and development expenses consist primarily of costs incurred to third -party service providers for the conduct of research, preclinical and clinical studies, contract manufacturing costs, license milestone fees, personnel costs for our research and development employees, consulting, and other related expenses.
Based upon that evaluation, our Chief Executive and Chief Financial Officers concluded that, as of December 31, 2023, our disclosure controls and procedures were effective. Management ’ s Annual Report on Internal Control over Financial Reporting.
Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2024, our disclosure controls and procedures were effective. Management ’ s Annual Report on Internal Control over Financial Reporting.
BRIUMVI first became commercially available in the United States in January of 2023. We also began shipping BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, in November 2023. Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not become profitable.
BRIUMVI first became commercially available in the United States in January of 2023. We also began shipping BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, in November 2023. Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not realize continued profitability.
Based upon management's assessment of all available evidence, we believe that it is more-likely-than- not that the deferred tax assets will not be realizable, and therefore, a valuation allowance has been established. The valuation allowance for deferred tax assets was approximately $418.3 million and $400.4 million as of December 31, 2023 and 2022 , respectively.
Based upon management's assessment of all available evidence, we believe that it is more-likely-than- not that the deferred tax assets will not be realizable, and therefore, a valuation allowance has been established. The valuation allowance for deferred tax assets was approximately $414.6 million and $418.3 million as of December 31, 2024 and 2023, respectively.
Other revenue for the year ended December 31, 2023 is comprised of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement. ​ Cost of Revenue.
Other revenue for the year ended December 31, 2023 is comprised of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement. 82 Table of Contents Cost of Product Revenue.
The 2022 WKSI Shelf is currently our only active shelf registration statement. We may offer any combination of the securities registered under the 2022 WKSI Shelf from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders.
We may offer any combination of the securities registered under the 2022 WKSI Shelf from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders.
The 2022 WKSI Shelf is currently our only active shelf-registration statement. We may offer any combination of the securities registered under the 2022 WKSI Shelf from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders.
We may offer any combination of the securities registered under the 2022 WKSI Shelf from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Form 10-K has been signed by the following persons on behalf of the Registrant on February 29, 2024, and in the capacities indicated: Signatures Title /s/ Michael S. Weiss Michael S. Weiss ​ Chairman, Chief Executive Officer and President ​ ​ ​ /s/ Sean A.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Form 10-K has been signed by the following persons on behalf of the Registrant on March 3, 2025, and in the capacities indicated: Signatures Title /s/ Michael S. Weiss Michael S. Weiss ​ Chairman, Chief Executive Officer and President ​ ​ ​ /s/ Sean A.
As of December 31, 2023 , the weighted-average remaining operating lease term was 5.8 years and the weighted-average discount rate for operating leases was 10.00%. Cash paid for amounts included in the measurement of operating lease liabilities during the year ended December 31, 2023 was $2.4 million.
As of December 31, 2024 , the weighted-average remaining operating lease term was 5.4 years and the weighted-average discount rate for operating leases was 10/04%. Cash paid for amounts included in the measurement of operating lease liabilities during the year ended December 31, 2024 was $2.4 million.
A portion of the performance obligation to supply BRIUMVI has not yet been satisfied, therefore, as of December 31, 2023, $5.9 million has been recorded as deferred revenue. During 2023 the Company recognized $3.2 million in BRIUMVI product sales, net related to performance obligations that were satisfied during the year ended December 31, 2023.
A portion of the performance obligation to supply BRIUMVI has not yet been satisfied, therefore, as of December 31, 2024, $23.5 million has been recorded as deferred revenue. During 2024 the Company recognized $3.7 million in BRIUMVI product sales, net related to performance obligations that were satisfied during the year ended December 31, 2024.
Our future minimum lease commitments include our office leases in New York, New Jersey and North Carolina as of December 31, 2023.
Our future minimum lease commitments include our office leases in New York and North Carolina as of December 31, 2024.
Securities Trading Plans of Directors and Executive Officers ​During the three months ended December 31, 2023, none of our directors or executive officers adopted or terminated a Rule 10b5 - 1 trading arrangement (as defined in Item 408 (a)( 1 )(i) of Regulation S-K) or adopted or terminated a non-Rule 10b5 - 1 trading arrangement (as defined in Item 408 (c) of Regulation S-K) for the purchase or sale of the Company’s securities that was intended to satisfy the affirmative defense conditions of Rule 10b5 - 1 (c). 67 Table of Contents PART III ITEM 10.
Securities Trading Plans of Directors and Executive Officers ​During the three months ended December 31, 2024, none of our directors or executive officers adopted or terminated a Rule 10b5 - 1 trading arrangement (as defined in Item 408 (a)( 1 )(i) of Regulation S-K) or adopted or terminated a non-Rule 10b5 - 1 trading arrangement (as defined in Item 408 (c) of Regulation S-K) for the purchase or sale of the Company’s securities that was intended to satisfy the affirmative defense conditions of Rule 10b5 - 1 (c).
During the year ended December 31, 2023, the Company recorded $8.7 million related to the worldwide royalty due under the LFB License Agreement in cost of revenue based on U.S. sales of BRIUMVI and as of December 31, 2023, approximately $3.9 million in royalties were payable under the LFB License Agreement.
During the year ended December 31, 2024, the Company recorded $30.7 million related to the worldwide royalty due under the LFB License Agreement in cost of revenue based on U.S. sales of BRIUMVI and as of December 31, 2024, approximately $10.3 million in royalties were payable under the LFB License Agreement.
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK. The primary objective of our investment activities is to preserve principal while maximizing our income from investments and minimizing our market risk. We currently invest in government and investment-grade corporate debt in accordance with our investment policy, which we may change from time to time.
The primary objective of our investment activities is to preserve principal while maximizing our income from investments and minimizing our market risk. We currently invest in government and investment-grade corporate debt in accordance with our investment policy, which we may change from time to time. The securities in which we invest have market risk.
The Company is eligible to receive an additional $12.5 million upon first key market commercial launch in the EU and up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones. In addition, TG will receive tiered double-digit royalties on net product sales up to 30%.
The Company received a $12.5 million milestone payment in 2024 upon the first key market commercial launch in the EU and is eligible to receive up to an additional $480.0 million in milestone-based payments on achievement of certain launch and commercial milestones. In addition, TG will receive tiered double-digit royalties on net product sales up to 30%.
On March 31, 2023 (the First Amendment Effective Date), the Company entered into a First Amendment to the Amended and Restated Loan and Security Agreement (the First Amendment) with Hercules.
Debt Financings On March 31, 2023 (the First Amendment Effective Date), the Company entered into a First Amendment to the Amended and Restated Loan and Security Agreement (the First Amendment) with Hercules Capital, Inc. (Hercules).
F- 14 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements NOTE 3 – INVESTMENT SECURITIES Our investments as of December 31, 2023 and 2022 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost.
F- 17 Table of Contents TG Therapeutics, Inc. and Subsidiaries Notes to Consolidated Financial Statements NOTE 3 – INVESTMENT SECURITIES Our short-term investments as of December 31, 2024 and 2023 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost.
As of December 31, 2023 , there was approximately $27.8 million of total unrecognized compensation expense related to unvested time-based restricted stock, which is expected to be recognized over a weighted-average period of 2.7 years.
As of December 31, 2024, there was approximately $36.0 million of total unrecognized compensation expense related to unvested time-based restricted stock, which is expected to be recognized over a weighted-average period of 2.8 years.
Substantially all our operating losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations, including our commercialization activities. As of December 31 2023, we had generated $ 92 .0 million in product revenue from sales of BRIUMVI.
Substantially all our operating losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations, including our commercialization activities. As of December 31, 2024, we generated $313.7 million in product revenue from sales of BRIUMVI.
BRIUMVI first became commercially available in the United States in January of 2023. Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not become profitable.
BRIUMVI first became commercially available in the United States in January 2023. Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not realize continued profitability.

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